Therapeutic hypothermia for moderate and severe hypoxic ischaemic encephalopathy in newborns using low-cost devices - ice packs and phase changing material.

Background: Different methods have been used for therapeutic hypothermia for neonates with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). As standard cooling devices are expensive, there is a need to establish the safety and efficacy of low-cost devices such as ice packs (IP) and phase changing material (PCM). Aim: To assess the efficacy and safety of therapeutic hypothermia (TH) and the clinico-laboratory profile of neonates who underwent cooling with IP or PCM. Methods: The study was retrospective. TH for moderate-to-severe HIE was initiated with IP between 2012 and 2014 and with PCM (MiraCradleTM) from September 2014. A standard protocol for inclusion and management during TH was used for all newborns. All data were collected by means of a local cooling registry. Results: Sixty-two cooled newborns (IP 29, PCM 33) were included in the study. Mean gestational age was 38.6 (1.7) weeks and mean birthweight 2920.6 g (450.7); 66.1% were inborn and 91.9% had moderate encephalopathy. Mean (SD) core temperature during cooling was 33.47°C (0.33) for PCM and 33.44°C (0.34) for IP. Adverse events observed during TH were thrombocytopenia (54.8%), coagulopathy (30.6%), shock (30.6%), skin changes (12.9%) and persistent pulmonary hypertension (8.1%). Forty-nine infants were discharged, two died and 11 were discharged against medical advice. TH was prematurely stopped in seven newborns with serious adverse events such as disseminated intravascular coagulation (DIC), gangrene and arrhythmia (IP 5, PCM 2). Conclusion: Low-cost devices are safe and effective alternatives for maintaining TH in low-resource settings with adequate monitoring. Abbreviations: DAMA, discharged against medical advice; DIC, disseminated intravascular coagulation; HELIX, Hypothermia for Encephalopathy in Low- and Middle-Income Countries Trial; HIE, hypoxic ischaemic encephalopathy; IP, ice packs; LMIC, low- and middle-income countries; NICHD, National Institute of Child Health and Human Development; PCM, phase changing; TH, therapeutic hypothermia (TH); TOBY, total body hypothermia for neonatal encephalopathy.

Low cost calibrated mechanical noisemaker for hearing screening of neonates in resource constrained settings.

BACKGROUND & OBJECTIVES: There is a need to develop an affordable and reliable tool for hearing screening of neonates in resource constrained, medically underserved areas of developing nations. This study valuates a strategy of health worker based screening of neonates using a low cost mechanical calibrated noisemaker followed up with parental monitoring of age appropriate auditory milestones for detecting severe-profound hearing impairment in infants by 6 months of age. METHODS: A trained health worker under the supervision of a qualified audiologist screened 425 neonates of whom 20 had confirmed severe-profound hearing impairment. Mechanical calibrated noisemakers of 50, 60, 70 and 80 dB (A) were used to elicit the behavioural responses. The parents of screened neonates were instructed to monitor the normal language and auditory milestones till 6 months of age. This strategy was validated against the reference standard consisting of a battery of tests - namely, auditory brain stem response (ABR), otoacoustic emissions (OAE) and behavioural assessment at 2 years of age. Bayesian prevalence weighted measures of screening were calculated. RESULTS: The sensitivity and specificity was high with least false positive referrals for 70 and 80 dB (A) noisemakers. All the noisemakers had 100 per cent negative predictive value. 70 and 80 dB (A) noisemakers had high positive likelihood ratios of 19 and 34, respectively. The probability differences for pre- and post- test positive was 43 and 58 for 70 and 80 dB (A) noisemakers, respectively. INTERPRETATION & CONCLUSIONS: In a controlled setting, health workers with primary education can be trained to use a mechanical calibrated noisemaker made of locally available material to reliably screen for severe-profound hearing loss in neonates. The monitoring of auditory responses could be done by informed parents. Multi-centre field trials of this strategy need to be carried out to examine the feasibility of community health care workers using it in resource constrained settings of developing nations to implement an effective national neonatal hearing screening programme.

Efficacy of a low cost protocol in reducing noise levels in the neonatal intensive care unit.

OBJECTIVE: To examine the effectiveness and cost of implementing a noise reduction protocol in a level III neonatal intensive care unit (NICU). METHODS: A prospective longitudinal study was done in a level III NICU, wherein a noise reduction protocol that included behavioral and environmental modification was implemented. The noise levels were measured sequentially every hour for 15 days before and after this intervention. The statistical significance of the reduction in noise levels after implementation of the protocol was tested by paired sample student's t-test. Cost was calculated using the generalized cost effectiveness model of the World Health Organisation. The present study has 80% power with 95% confidence to measure 2 dB differences between groups for the maximum recommended of 50 dB. RESULTS: The protocol in the present study reduced noise levels in all the rooms of the NICU to within 60 dB with high statistical significance (p< 0.001). The extent of noise reduction in the rooms of the NICU was as follows: ventilator room by 9.58 dB (95% confidence interval: 6.73-12.42, p < 0.001), stable room by 6.54 dB (95% confidence interval: 2.92-4.16, p < 0.001), isolation room by 2.26 dB (95% confidence interval: 1.21-3.30, p < 0.001), pre-term room by 2.37 dB(95% confidence interval: 1.22-3.51, p < 0.001) and extreme preterm room by 2.09 dB (95% confidence interval: 1.14-3.02, p < 0.001). The intervention was most cost-effective in the ventilator room, requiring Rs. 81.09 to reduce 1 dB and least effective in the extreme pre-term room requiring Rs. 371.61 to reduce 1 dB. CONCLUSION: The high efficacy and affordability of noise reduction protocols justify the need for implementation of these measures as a standard of care in neonatal intensive care units.