There was no evidence that the procedure caused any injury to or, significant removal of vernix from the skin, and any associated skin aggravation (i.e., redness) was transient. The lower temperature readings after the procedure, however, indicate that newborns cleansed in this manner are likely to lose heat through conduction and evaporation. The mean change in temperature (0.4 °C) was comparable to temperature loss recently reported among tub-bathed (0.2 °C) and sponge-bathed (0.4 °C) infants in a Canadian hospital-based study.(13
) reported a mean temperature loss of 0.1 °C among 20 infants bathed in a deep-water bath, while Medves(15
) estimated a mean temperature decrease of 1.2 °C and 1.5 °C among 111 infants washed by mothers and nurses, respectively. In another study, among 80 newborns bathed within 2 hours of birth, the decrease in temperature ranged from 0.1 to 1.0 °C.(16
) Thus, although the skin cleansing procedure is unlike a submersion or sponge bath, the risk for loss of body heat appears to be on the order of or less than that encountered during these bathing procedures.
Hypothermia in the newborn increases risk of illness and death, and is related to gestational age and weight at birth.(12
) In this pilot study, infant weight was not recorded, precluding an examination of body temperature change stratified by infant weight. The mean time between birth and cleansing was almost 24 hours in this pilot study, and age at the time of the procedure was not associated with body temperature change. During the main trial of impact of chlorhexidine cleansing, however, the average time to cleansing was significantly closer to the time of birth (approximately 6 hours), as WDs provided the intervention directly upon learning of the birth, and did not wait for AC supervision to apply the treatment. Others have examined axillary temperature and temperature loss within the first six hours after birth, finding little evidence for an association between age and temperature loss after bathing during these initial hours after birth.(16
) While the time of day when the procedure was conducted may have impacted the changes in temperature, we did not attempt to standardize this aspect of the procedure as the subsequent large trial of antiseptic cleansing aimed to deliver the intervention as soon as possible after birth without regard to time.
Although the body temperature loss recorded here was low and comparable to or less than reductions seen among newborns undergoing routine care in developed country hospital settings, the potential drop in temperature during the procedure does warrant increased emphasis and attention during training. All trainees should be given adequate messages concerning hypothermia risk. Moreover, the entire temperature decrease should not be attributed to the cleansing procedure alone, as infants are also likely to lose heat while the swaddling clothes are removed. Therefore, the importance of prompt and consistent wrapping of the newborn, kangaroo-mother care, or extra swaddling as appropriate to the culture, should also be emphasized. In periods or settings where the ambient temperature is lower than encountered during this study in April in Nepal, further emphasis on hypothermia prevention may be warranted.
Despite WHO recommendations for delayed bathing of newborns for at least 6 hours after birth(12
), previous research in the study area showed that 95% of families conduct a wet wash of the newborn within the first 12 hours after delivery.(18
) This routine practice in the community, combined with rigorous massage of newborns with mustard seed oil(18
), may result in rapid removal of much of the vernix. Among the infants assessed for removal of vernix during the procedure, many did not have sufficient vernix remaining after the traditional bath by the family that typically was given before the baby was reached by study personnel. Among the infants who did have residual vernix after the traditional bath, there was no evidence of further removal of vernix during the study procedure. Thus, while it is important to emphasize gentle contact with the skin during skin wiping, and thus to avoid vernix removal or skin irritation, further research is needed on effective ways to promote delayed bathing and appropriate methods of skin cleansing of newborns by families(19
Data collected during this pilot study aided in the design of the final protocol for wiping newborns in the community. For example, given the small amount of moisture present on the skin after the procedure and the residual antimicrobial effect of chlorhexidine (20
), we decided to allow any moisture on the skin to remain after the wiping procedure, thus also avoiding any further wiping/rubbing process that might aggravate the skin or remove vernix. During training of our field workers, we emphasized the importance of completing the wiping procedure as quickly and gently as possibly, and promptly wrapping the child after the last wipe was used. We also provided all WDs with a bar of soap to be used for hand-washing before conducting the cleansing procedure. While the five wipes were sufficient in this pilot study for cleansing the infants, for the main trial we included a sixth wipe in the package in the event that one of the wipes became soiled.
Community health workers can be trained to conduct full-body cleansing of newborns in a simple and acceptable manner. If a safe and effective broad-spectrum antiseptic solution were readily available, this procedure represents an acceptable method for delivering that antiseptic to newborns in the community. A leading candidate is chlorhexidine, which has been used extensively as a topical and surgical antiseptic for the past five decades and has a strong safety record.(10
) Studies of full-body cleansing of neonates have shown minimal to no percutaneous absorption through the skin (21
), and no indication that any trace absorption has negative effects. In hospital-based studies in Malawi(8
) and Egypt(9
), respectively, 3743 and 2295 babies were wiped with a cloth soaked in 0.25% chlorhexidine solution immediately after birth with no reported adverse events.
These pilot study data indicate that full-body cleansing of neonates can be conducted in the community with minimal or no risk to infants. A slight decrease in body temperature during the procedure could be minimized with protective measures and educational messages. The minimal risks highlighted in this pilot study or those associated with chlorhexidine must be considered in a balanced way with the potentially significant positive impact of full-body or umbilical cord cleansing with chlorhexidine on neonatal infections and death. In the hospital-based studies in Malawi and Egypt, neonatal mortality was reduced in the chlorhexidine group by 22% and 33%, respectively(8
), while mortality among low birth weight infants was reduced by 28% in the Nepal community-based study(11
Skin cleansing in the community represents a safe, simple, affordable, and potentially easily-implemented intervention to reduce neonatal mortality. Further investigations of the optimal concentration of chlorhexidine solution and identification of the most effective community-based delivery methods for chlorhexidine cleansing of newborns is warranted.