A randomized comparative trial of two different strategies to reduce insensible water loss in preterm infants of less than 32 weeks gestation in the first postnatal week

Preterm newborns are subjected to significant thermal stress beginning from birth till their discharge from hospital. Most vulnerable period is right at birth in the labor room (LR) or operation theatre (OT) which is usually maintained at the comfort level for the caregivers. Newborns are subjected to all the processes of heat loss at LR/OT. Evaporative loss from skin and respiratory tract is the major cause of hypothermia and excessive weight loss of extremely preterm infants in first weeks of life. A food grade plastic wrap to cover the preterm infant from neck to foot without drying at birth is most widely used and significantly reduces incidence of admission hypothermia. However combined use of cling wrap and plastic wrap in preterm infants in the first postnatal period is not yet standardized because of fear of hyperthermia, sepsis and skin rash. Combined use of polyethylene occlusive wrap along with cling wrap might reduce insensible water loss (IWL) more effectively than cling wrap alone in an open care setting in postnatal period. However, there is no head to head comparison between these 2 approaches in first few weeks of life.  

Parents will be counselled before birth regarding the importance of maintaining thermal comfort for the baby in postnatal life. Gestational age will be checked before birth by first trimester dating scan and LMP. Best obstetric estimate of gestational age will be taken. If the baby is anticipated to be < 32 weeks, a neonatologist fellow will attend the delivery. Baby will be received in a polyethylene occlusive plastic wrap without drying and standard NRP 2020 guidelines will be followed for resuscitation. After excluding exclusion criteria parents will be approached for written informed consent. If refused, baby will not be enrolled in the study. Babies will be randomized in intervention(cling plus occlusive plastic wrap under radiant warmer) and control arm(only cling wrap under radiant warmer). This allocation will continue for the first seven days of life. Thereafter babies will be kept as per the discretion of the treating physician.

Babies will be monitored for serious and significant adverse events. Serious adverse effects  will include any cause mortality, consecutive weight gain by >3 % for 3 consecutive days, excessive daily weight loss of > 3% for 3 consecutive days, excessive cumulative weight loss > 20%. Significant adverse effects will include any incidence of severe hyponatremia (< 120 meq/L), severe hypernatremia (> 150 meq/L), severe hyperthermia(> 390C), severe hypothermia (<320C).   Significant increase in serious and significant adverse effects  in  any group will prompt the investigators to stop the trial. An interim analysis is planned at 50% of sample recruitment.