Advances in Preventive Medicine
Volume 2014 (2014), Article ID 415301, 5 pages
http://dx.doi.org/10.1155/2014/415301

Research Article

Usage of EMBRACETM in Gujarat, India: Survey of Paediatricians

Somashekhar Nimbalkar,1,2 Harshil Patel,¹ Ashish Dongara,¹ Dipen V. Patel,¹ and Satvik Bansal¹

¹Department of Paediatrics, Pramukhswami Medical College, Anand, Karamsad, Gujarat 388325, India
²Central Research Services, Charutar Arogya Mandal, Anand, Karamsad, Gujarat 388325, India

Received 26 June 2014; Revised 26 September 2014; Accepted 10 October 2014; Published 30 October 2014

Academic Editor: Masaru Shimada

Copyright © 2014 Somashekhar Nimbalkar et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract.

Aim. EMBRACETM is an innovative, low cost infant warmer for use in neonates. It contains phase change material, which stays at constant temperature for 6 hours. We surveyed paediatricians using EMBRACETM regarding benefits, risks, and setup in which it was used in Gujarat. Methods. Questionnaire was administered telephonically to 52 out of 53 paediatricians. Results. EMBRACETM was used for an average of 8.27 (range of 3–18, SD = 3.84) months by paediatricians. All used it for thermoregulation during transfers, for average (SD) duration of 42 (0.64) m per transfer, 62.7% used it at mother’s side for average (SD) 11.06 (7.89) h per day, and 3.9% prescribed it at home. It was used in low birth weight neonates only by 56.9% while 43.1% used it for all neonates. While hyperthermia was not reported, 5.9% felt that EMBRACETM did not prevent hypothermia. About 54.9% felt that they could not monitor the newborn during EMBRACETM use. Of paediatricians who practiced kangaroo mother care (KMC), 7.7% have limited/stopped/decreased the practice of KMC and substituted it with EMBRACETM. Conclusions. EMBRACETM was acceptable to most but concerns related to monitoring neonates and disinfection remained. Most paediatricians felt that it did not hamper KMC practice.

1. Introduction

Lack of thermal protection is one of the major challenges faced by developing nations for newborn survival [1]. In India, the prevalence of hypothermia varies widely but recent estimates in normal newborns in community settings are around 31% and about 32% in hospital settings, but these included mostly normal weight newborns [2, 3]. The prevalence can be estimated to be even higher for low birth weight newborns. A greater proportion of child deaths in the western and southern parts of India are attributable to low birth weight and premature babies [4]. Almost 2.8 million neonatal deaths occurred in the year 2013 globally, of which 73% deaths occurred during the first seven days of life [5]. Neonatal mortality contributes to more than half of the under-five mortality in countries such as India [5]. The rates of decline in the last decade have been the slowest for neonatal mortality [6]. Every 1°C below 36°C on admission increased the odds of late onset sepsis by 11% and of death by 28% [7].

Hypothermia in newborns is rarely a direct cause of death but rather exists as a comorbid condition along with birth asphyxia, neonatal infections, and preterm birth and leads to a substantial amount of mortality. The hypothalamus along with various endocrine organs is responsible for the process of thermoregulation in newborns. In LBW and preterm babies, these mechanisms are overwhelmed resulting in metabolic disturbances which ultimately result in neonatal death, either directly by hypothermia or indirectly [1]. In preterm infants there can be a rapid drop in temperature by almost 0.5°C to 1°C per minute. Cold ambient temperature, intrahospital transfers, low temperature of hospital beds and poor warm chain practices during resuscitation, and late onset of breastfeeding, and so forth, are some additional factors which hasten the onset of hypothermia [8]. In a recent study of 300 consecutive neonates, almost 47% neonates had hypothermia in spite of about 75% being institutional deliveries [9]. In developing countries neonatal hypothermia often goes unnoticed and unaddressed [10].

Various measures to prevent hypothermia are practiced by healthcare providers and these vary with the population of neonates being catered to. Maintaining a delivery room temperature of more than 25°C, wrapping the baby in clean linen, drying, using baby hat, starting skin-to-skin contact with mother after delivery also termed as kangaroo mother care, placing the neonate under radiant warmer, delaying bathing, usage of chemical mattresses, and wrapping the neonate in plastic are all practiced by healthcare providers [11]. Kangaroo mother care has shown to prevent hypothermia along with other benefits to the child which include increased breast feeding and better weight gain [12]. An estimated 4,50,000 babies can be saved worldwide every year if supportive care in the form of kangaroo mother care is provided by healthcare providers [13]. The most recent systematic review on kangaroo mother care in low birth weight infants has shown a reduction in the risk of mortality (risk ratio of 0.60, 95% confidence interval (CI) 0.39 to 0.92) as well as reduction in the risk of hypothermia (risk ratio of 0.34, 95% CI 0.17 to 0.67) and reduction of nosocomial infection/sepsis (risk ratio of 0.45, 95% CI 0.27 to 0.76) when evaluated at discharge or 40-41 weeks postmenstrual age. Even at the latest follow-up the KMC was associated with reduction of mortality and sepsis [14]. In areas where there are fewer healthcare providers and even lesser resources a simple technique to prevent and manage hypothermia is required. The EMBRACETM warmer is a small sleeping bag-like apparatus which has in its back a reusable pouch of phase change material that can be heated to 37°C and can maintain that temperature for several hours. It is cheap, reusable, portable, and hygienic and does not require constant electricity [15]. This has been developed by students at Stanford University and has been marketed in India for the last two years. There have been no published trials of EMBRACETM though there are four studies which are listed on clinical trial registries [16–19]. We surveyed users of EMBRACETM in Gujarat for their assessment of its benefits and the various settings in which it was being used.

2. Materials and Methods

The survey questionnaire was developed and was consensually validated by four neonatologists at the neonatal intensive care unit (NICU) of Shree Krishna Hospital, Karamsad (Appendix). Over a span of 2 months, the questionnaire was administered by telephone to 52 out of a population of 53 practitioners who were using EMBRACETM at their setups in different cities across the state of Gujarat. One paediatrician declined to answer the survey. The study was approved by the institutional ethics committee.

Instrument. The questionnaire comprised of 22 questions regarding the use of EMBRACETM, for instance, what were the indications for using EMBRACETM, the average duration of the use of the product per day, major advantages and disadvantages as experienced by the paediatricians while using EMBRACETM, and the impact of EMBRACETM on the practice of kangaroo mother care. Demographic information of the hospitals at which the participating paediatricians practiced was also taken into account.

3. Results

The paediatricians have been using EMBRACETM since a mean time of 8.27 months (range = 3–18 months, ). The product is mainly used for thermoregulation during transfers (100%) and during hospital stay when the baby is at the mother’s side (62.7%) and is even prescribed at home in a small proportion of cases (3.9%). When used for transfers, EMBRACETM was utilized for a mean (SD) duration of 42 (0.644) minutes per transfer, and when used to keep the baby warm while at the mother’s side, it was used for a mean duration of 11.06 h () a day.

We attempted to determine the target population for EMBRACETM use. We found that 56.9% of paediatricians used it for low birth weight neonates and 43.1% paediatricians used it for normal weight and low birth weight neonates. None of the paediatricians used the product after delivery unless the neonate was vitally stable. Of all the paediatricians, 54.9% used EMBRACETM within 12 h of delivery, 31.4% used it within 12–48 h after delivery, and 13.7% used it after 48 h of delivery.

We determined that 98% of the paediatricians were comfortable using the product routinely and 100% of the paediatricians felt that the babies were comfortable while placed in EMBRACETM. All of the paediatricians (100%) found EMBRACETM to be a useful product for transfers, both intra- and interhospital. More than half of the paediatricians (58.8%) did not report any disadvantage or problems while using EMBRACETM, while the rest encountered one problem or the other. Of the paediatricians, 14.3% felt that EMBRACETM was too costly and not worth its price, 33.3% reported issues related to heating and temperature regulation related issues, 33.3% paediatricians had issues related to cleaning, disinfection, size issues (too large for ELBW infants), charging, and monitoring, and 19% paediatricians found a combination of the above-mentioned issues.

Of the paediatricians using EMBRACETM for babies kept at the mother’s side, 94.1% did not notice any weight gain in infants and 62.7% found it to prevent hypothermia when the baby was at the mother’s side. But, 5.9% paediatricians did not find EMBRACETM to be a useful product to prevent hypothermia in newborns. No doctor reported hyperthermia as a consequence of EMBRACETM use.

Out of all the paediatricians using EMBRACETM, 54.9% felt that they could not monitor the newborn effectively when placed within EMBRACETM. Of those who felt that they could monitor the infant, 95.7% monitored only pulse oximetry, whereas 4.3% said that they monitored both the chest rise of the baby and pulse oximetry readings.

All the participating paediatricians (100%) had heard about kangaroo mother care, out of which 98% were formally trained in kangaroo mother care (KMC), and 74.5% paediatricians practiced KMC at their setup. Of the paediatricians who practiced KMC, 7.7% have limited/stopped/decreased the practice of KMC and substituted it with EMBRACETM for thermoregulation. All 7.7% of these doctors were involved in private sector. On further questioning, healthcare providers gave various reasons for reducing KMC. These included “more compliance of EMBRACETM with nurses and relatives,” “counselling for KMC requires 30 minutes,” “training staff is a headache,” “hygiene issues in mother,” “EMBRACETM is equivalent to KMC,” “KMC is not possible in private setups,” and “there is no space to give KMC.” 90.4% paediatricians included in the study were from private sector whereas only 9.6% were from public sector. Among the doctors who were involved in private practice, 27.6% did not practice KMC at all whereas all the doctors in public sector practiced KMC at their setups. EMBRACETM was being used for babies kept by mother’s side by 38.2% private practitioners, whereas only 1 out of the 5 practitioners in public sector used the product for this purpose. Ninety-two percent paediatricians levied no charges on the patients for using this product, whereas 8% paediatricians levied nominal charges for maintenance of the product. No doctor charged more than 500 rupees per day.

4. Discussion

The current survey reports on the usage of EMBRACETM of almost all healthcare providers having EMBRACETM in Gujarat in mid-2013. In a recent survey on neonatal resuscitation carried out in Gujarat there were a similar number of participants that participated and hence we believe that this survey on EMBRACETM is representative of current neonatal practice in Gujarat [20].

Although published literature on the benefits of EMBRACETM is not available the fact that it has a relatively large number of users within a short period of time is an indicator of the need for a low-cost product to prevent neonatal hypothermia. It can be argued that KMC is a better and proven intervention than EMBRACETM for management of hypothermia. However providing KMC encompasses support from the family and the healthcare providers. Though the current study has not addressed this aspect, the authors surmise that this support is not available due to rapid uptake of EMBRACETM and a sizeable number of providers stopping KMC. Additionally though a neonate can be transferred while in KMC position with mother/relative, it is often not feasible because of unavailability of mother/relative to provide KMC during transfers or in case of urgent intra- or interhospital transfers of neonates when there is not enough time to prepare the mother/relative for providing KMC, and so the use of a low-cost product like EMBRACETM to prevent neonatal hypothermia is warranted.

The results indicate that these healthcare workers are comfortable with using EMBRACETM suggesting that the design of the product is simplistic in nature and does not require extensive training. Incubators and radiant warmers are complex devices which are costly and require training and their usage practices vary with different neonatal units, experience, and knowledge [21]. Availability of EMBRACETM allows healthcare providers to use it in situations wherein they would have utilized a radiant warmer with all of its attendant technical requirements, especially when KMC would be nonfeasible to implement as already mentioned. Using EMBRACETM as a sleeping bag kind of mattress allows the paediatricians to reduce the complexity of care. Usage of EMBRACETM for transport had universal appeal as compared to kangaroo mother care which requires training and extensive support before it can be effectively used. However the short duration of transport does not shed any information of value, as increased neonatal mortality occurs when the transport duration exceeds 1 h [9].

Healthcare providers shared their concerns about cleaning, disinfection, and temperature regulation of the neonates. This is surprising as the training of EMBRACETM and the literature pack provided describes these in detail. The concerns related to the EMBRACETM warmer being large for ELBW babies are notable. EMBRACETM is provided with a cushion for smaller neonates. However there was no specific problem related to usage in ELBW babies. Almost 40% healthcare providers expressed their apprehension about the effectiveness of the product in preventing hypothermia although they were all comfortable using it. Whether it is a design issue or a training issue cannot be commented upon, due to the design of our survey. More detailed understanding of these concepts is needed. There was not a single report of hyperthermia which possibly indicates the safety of EMBRACETM though our study design was not designed to study safety features. This is significant as EMBRACETM is being utilized in community settings across the world with minimal supervision by healthcare personnel. In a recent study of a thermal regulation bundle there was 2% incidence of temperatures >38°C in a very low birth weight (VLBW) population [22]. Inability to monitor the baby was another lacuna that EMBRACETM has in a hospital setting. EMBRACETM has an internal monitor for temperature of the phase change material but baby’s temperature cannot be monitored. The healthcare providers also monitored oxygen saturation in these babies.

Kangaroo mother care is being proposed as a better alternative to conventional care with wide ranging benefits including reduction of neonatal mortality, hypothermia, and length of hospital stay [23]. There are many more benefits that accrue from KMC such as reducing maternal postpartum depression, neonatal pain reduction, prolonged breastfeeding, and positive infant development and parent child bonding. This has led to the concept that premies are exterogestational foetuses that require provision of continuous skin-to-skin contact to promote maturation [24]. It is well acknowledged that only a fraction of the neonates requiring KMC are receiving it. It probably stems from viewing KMC as an option available to poor people in low income countries, from absence of knowledge or from lack of engagement of parents [24]. Measures to accelerate KMC need to be put in place [25]. It is in this context that the finding that almost 75% of the surveyed healthcare providers were using KMC was gratifying. However, almost 8% had reduced/stopped the practice of KMC after beginning to use EMBRACETM. While EMBRACETM does prevent hypothermia it does not have the additional advantages that KMC has. The authors believe that this finding has serious implications for neonatal health in the long term. Efforts to promote KMC will possibly face stiff resistance from healthcare providers using EMBRACETM as it is a therapy which is easy to administer and even easier to monitor. KMC on the other hand requires training of staff, counselling of parents who are often unwilling and if given an alternative may choose EMBRACETM, monitoring, and larger space utilization in the hospital. The benefits of KMC are more in the long term and are not really seen or felt by the healthcare provider. With the introduction of technology in the form of ultrasound machines in the 1980s there has been a reduction of the sex ratio in India to alarming levels [26]. There has been no head-to-head trial of EMBRACETM versus KMC. It may be unethical to conduct one in most settings as equipoise is no longer present. Yet the authors believe that a trial which compares these modalities of neonatal thermal management is necessary, albeit in a design which is ethical. EMBRACETM may yet be utilized as an adjunct to KMC in situations where provision of KMC may be challenging. Studies focusing on the situations where these challenges can be faced and complimented by EMBRACETM need to be undertaken.

5. Conclusions

EMBRACETM is being used not only for transport but also for stabilization of the neonate in the neonatal intensive care unit. Paediatricians are using it in both LBW and normal weight newborns and some have concerns related to disinfection and monitoring of neonates. However, most paediatricians felt that it did not hamper the practice of kangaroo mother care. As EMBRACETM usage increases, researchers working in this area need to focus on developing strategies to improve the uptake of kangaroo care while providing evidence based guidelines for the usage of EMBRACETM. Efforts need to be made to publish studies related to efficacy and effectiveness of EMBRACETM in clinical care of neonates.

Appendix

(1)Name.(2)Since when has been used? (in months).(3)In what kind of babies did you use ? Normal birth weight, low birth weight, or both.(4)What was the purpose of use? Purpose of use—transfers, prevent or treat hypothermia when baby is out of NICU or is with mother, both.(5)Were there any charges levied if any? (in rupees).(6)Within how much time did the use of start after delivery? Immediately, after initial stabilization (within 6 hours), within 6–48 hours, or after 48 hours.(7)What was the duration of use of per day in newborns for transfers? (in hours).(8)What was the duration of use of per day in newborns for purposes other than transfers? (in hours).(9)Did you notice any pattern of weight gain in babies after the use of ? Yes, No.(10)Are you comfortable in using or not? Yes, No.(11)What are the major benefits of noticed? No benefits, transfers, maintaining warm temperatures while at mother’s side, or combination of any.(12)Have any newborns developed hypothermia while placed in ? Yes, No.(13)Have any newborns developed hyperthermia while placed in ? Yes, No.(14)Are newborns comfortable while placed in ? Yes, No.(15)Do you use for transfers? Yes, No.(16)Are you able to monitor newborns kept in ? Yes, No. If yes, what parameters can you monitor? Respiration (chest rise), pulse oximetry, or both.(17)Is there any disadvantage of using ? Yes, No. If yes, costly product, heating and temperature regulation related issues, other technical issues like size too big for ELBW babies, charging, cleaning, and monitoring issues, or combination of any.(18)Have you heard of kangaroo mother care? Yes, No.(19)Have you been trained in kangaroo mother care formally or otherwise? Yes, No.(20)Have you ever used kangaroo mother care at your setup before today? Yes, No.(21)Did you stop/limit/decrease using KMC after buying and using ? Yes, No, or not applicable as never used KMC.(22)What is the number of hours that you subject the baby to KMC? (in hours).(23)Address of the hospital.

Conflict of Interests

None of the authors have any conflict of interests to disclose.

Acknowledgments

Thanks are due to Central Research Services, Karamsad, for providing statistical support and review of the paper and Amee Amin for editing the paper. This work was supported by all the authors themselves.

References

K. Lunze, D. E. Bloom, D. T. Jamison, and D. H. Hamer, “The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival,” BMC Medicine, vol. 11, no. 1, article 24, 2013.

S. M. Nimbalkar, V. K. Patel, D. V. Patel, A. S. Nimbalkar, A. Sethi, and A. Phatak, “Effect of early skin-to-skin contact following normal delivery on incidence of hypothermia in neonates more than 1800 g: randomized control trial,” Journal of Perinatology, vol. 34, no. 5, pp. 364–368, 2014.

S. Agarwal, V. Sethi, K. Srivastava, P. Jha, and A. H. Baqui, “Human touch to detect hypothermia in neonates in Indian slum dwellings,” Indian Journal of Pediatrics, vol. 77, no. 7, pp. 759–762, 2010.

Million Death Study Collabor, D. G. Bassani, R. Kumar, et al., “Causes of neonatal and child mortality in India: a nationally representative mortality survey,” The Lancet, vol. 376, no. 9755, pp. 1853–1860, 2010.

“Levels and trends in child mortality. Report 2014,” http://www.childmortality.org/

R. Lozano, H. Wang, K. J. Foreman, et al., “Progress towards Millennium development goals 4 and 5 on maternal and child mortality: an updated systematic analysis,” The Lancet, vol. 378, no. 9797, pp. 1139–1165, 2011.

A. R. Laptook, W. Salhab, and B. Bhaskar, “Admission temperature of low birth weight infants: predictors and associated morbidities,” Pediatrics, vol. 119, no. 3, pp. e643–e649, 2007.

M. Manani, P. Jegatheesan, G. DeSandre, D. Song, L. Showalter, and B. Govindaswami, “Elimination of admission hypothermia in preterm very low-birth-weight infants by standardization of delivery room management,” The Permanente Journal, vol. 17, no. 3, pp. 8–13, 2013.

M. Narang, J. S. Kaushik, A. K. Sharma, and M. M. Faridi, “Predictors of mortality among the neonates transported to referral centre in Delhi, India,” Indian Journal of Public Health, vol. 57, no. 2, pp. 100–104, 2013.

L. C. Mullany, J. Katzj, S. K. Khatry, S. C. LeClerq, G. L. Darmstadt, and J. M. Tielsch, “Neonatal hypothermia and associated risk factors among newborns of southern Nepal,” BMC Medicine, vol. 8, article 43, 2010.

R. F. Soll, “Heat loss prevention in neonates,” Journal of Perinatology, vol. 28, supplement 1, pp. S57–S59, 2008.

A. Cattaneo, R. Davanzo, B. Worku et al., “Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings,” Acta Paediatrica, International Journal of Paediatrics, vol. 87, no. 9, pp. 976–985, 1998.

“Born too soon: the global action report on preterm birth,” http://www.who.int/pmnch/media/news/2012/201204_borntoosoon-report.pdf

A. Conde-Agudelo and J. L. Diaz-Rossello, “Kangaroo mother care to reduce morbidity and mortality in low birthweight infants,” Cochrane Database of Systematic Reviews, 2014.

EMBRACE, “EMBRACE Warmer,” 2014, http://EMBRACEglobal.org/EMBRACE-warmer/

V. Bhutani and N. Mang, “Clinical performance of the EMBRACE isothermal mattress in stabilizing temperatures of the preterm infants during thermal weaning,” in Clinical Trials.gov, National Library of Medicine (US), Bethesda, Md, USA, 2012, http://clinicaltrials.gov/ct2/show/NCT01425086.

R. Kishore Kumar, R. A. Panicker, and K. Chattopadhyay, “A randomized, controlled trial to study the efficacy of EMBRACE Infant Warmers in maintaining thermostability of low birth weight neonates against conventional care,” in Clinical Trials Registry India [Internet], Database Publisher (India), New Delhi, India, 2010, http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1940.

R. Kishore Kumar, R. A. Panicker, and K. Chattopadhyay, “A randomized, active controlled, open label study to determine the non-inferiority of EMBRACE Infant Warmers against the Standard of Care in maintaining thermo stability of low birth weight neonates,” in Clinical Trials Registry India, Database Publisher, New Delhi, India, 2010, ACRONYM: NEW (Neonatal Easy Warming), http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2321.

G. S. Kumar and K. Chattopadhyay, “A randomized, open-label, active controlled study to determine the efficacy of the EMBRACE Care in maintaining normothermia (36.5°C to 37.5°C) in low-birth-weight (LBW) neonates (1500 to 2000 grams) as compared to the currently available routine practice of attempting to maintain normothermia in the community setting,” in Clinical Trials Registry India, Database Publisher, New Delhi, India, 2013, http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5745.

S. C. Bansal, A. S. Nimbalkar, D. V. Patel, et al., “Current neonatal resuscitation practices among paediatricians in Gujarat, India,” International Journal of Pediatrics, vol. 2014, Article ID 676374, 7 pages, 2014.

S. Blackburn, D. DePaul, L. A. Loan et al., “Neonatal thermal care, part I: survey of temperature probe practices,” Neonatal Network, vol. 20, no. 3, pp. 15–18, 2001.

J. M. B. Pinheiro, S. A. Furdon, S. Boynton, R. Dugan, C. Reu-Donlon, and S. Jensen, “Decreasing hypothermia during delivery room stabilization of preterm neonates,” Pediatrics, vol. 133, no. 1, pp. e218–e226, 2014.

A. Conde-Agudelo, J. M. Belizan, and J. Diaz-Rossello, “Kangaroo mother care to reduce morbidity and mortality in low birthweight infants,” The Cochrane Database of Systematic Reviews, no. 3, Article ID CD002771, 2011.

K. H. Nyqvist, G. C. Anderson, N. Bergman et al., “Towards universal Kangaroo Mother Care: recommendations and report from the First European conference and Seventh International Workshop on Kangaroo Mother Care,” Acta Paediatrica, vol. 99, no. 6, pp. 820–826, 2010.

C. Engmann, S. Wall, G. Darmstadt, B. Valsangkar, and M. Claeson, “Consensus on kangaroo mother care acceleration,” The Lancet, vol. 382, no. 9907, pp. e26–e27, 2013.

M. Sahni, N. Verma, D. Narula, R. M. Varghese, V. Sreenivas, and J. M. Puliyel, “Missing girls in India: Infanticide, feticide and made-to-order pregnancies? Insights from hospital-based sex-ratio-at-birth over the last century,” PLoS ONE, vol. 3, no. 5, Article ID e2224, 2008.