Safety and efficacy of double plastic wrap in reducing insensible water loss in preterm infants in first week of life - a pilot randomized controlled trial from a low-to-middle-income country.

Background: Preterm infants experience excessive insensible water loss in postnatal period. Established practices like cling film might not be sufficient alone in reducing this loss. Being expensive, humidified incubators might not be affordable in developing countries. Hence, we tried to explore double plastic wrap (cling film attached to the bassinet wall and occlusive plastic wrap covering the baby) as a low-cost solution of increased insensible water loss in postnatal period.

Methods: In this pilot trial 63 inborn infants of less than 32 weeks of gestation or birth weight less than 1200 g were enrolled and randomized to either single wrap (only cling film attached to the bassinet wall) or double wrap (cling film covering the bassinet and occlusive plastic wrap covering the baby) group after birth. This practice was allowed in addition to radiant warmer care and other routine thermoregulatory measures followed in the unit. Intervention was continued till first 7 days of life unless they met any pre-specified withdrawal criteria. The primary outcome was a difference in total insensible water loss (g/m2) in first seven days of life between two groups. The secondary outcomes were difference in cumulative insensible water loss (g/m2) in the first 72 h of life, 4-7 days of life, average daily insensible water loss in the first week (g/m2/h), neonatal morbidities, mortality and time to event analysis.

Results: Of 63 randomized infants, 32 were allocated to single wrap and 31 to double wrap groups. Cumulative insensible water loss in first 72 h and first week were significantly lower in the double wrap group (2786.5 ± 576 g/m2 in single wrap and 2376.8 ± 626 g/m2 in double wrap, p value 0.012 for 0-3 days and 6225.48 ± 951 g/m2 in single wrap and 5260.61 ± 1091 in double wrap, p value 0.034 for 0-7 days of life respectively). Apart from increased incidence of patent ductus arteriosus in double wrap group (41.94% vs. 15.62%, p 0.027) no other clinically significant outcomes were different between 2 groups. Median times to wean off respiratory support, regain birth weight and discharge from health facility were also similar between the two groups.

Conclusion: Double plastic wrap has been found to reduce cumulative insensible water loss in first week of life compared to cling film alone in the setting of a low-to-middle income-country.

Trial registration number: CTRI/2024/03/063749.

Trial registration date: 07.03.2024. LINK TO CTRI: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAwMzk5&Enc=&userName=CTRI/2024/03/063749 .