Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial.

IMPORTANCE

Newborn oil massage, a traditional community practice, could potentially benefit thermoregulation and skin barrier function, and prevent serious infections, morbidity and mortality in high-risk preterm infants, but has only been evaluated in limited studies in low income settings.

OBJECTIVES

To assess the efficacy of topical coconut oil applications among a cohort of hospital-born preterm infants.

DESIGN

A prospective, individually randomised controlled clinical trial.

SETTING

Nursery and neonatal intensive care unit at Aga Khan University Hospital, Pakistan.

PARTICIPANTS

Of 270 eligible neonates, a consecutive cohort of 258 hospital-born preterm infants (gestational age ≥26 weeks and ≤37 weeks).

INTERVENTION

Twice daily topical application of coconut oil by nurses from birth until discharge and continued thereafter by mothers at home until completion of the 28th day of life.

PRIMARY OUTCOME MEASURES

Incidence of hospital-acquired bloodstream infections.

SECONDARY OUTCOME MEASURES

Weight gain, skin condition and neonatal mortality.

RESULTS

23% of the enrolled neonates developed clinically suspected sepsis while 14% developed blood culture proven infection. The unadjusted hazard for developing hospital-acquired infection in the control group was 4.7 (95% CI 1.8 to 12.4) compared with the intervention group. After adjusting for gestational age, birth weight, duration of intubation and duration of hospitalisation for possible confounding, the hazard for hospital-acquired infection in the control group was 6.0 (95% CI 2.3 to 16) compared with the intervention group. The rate of hospital-acquired infections in the control and intervention groups was 219.1 and 39.5 per 1000 patient-days, respectively. Mean weight gain was 11.3 g/day higher (95% CI 8.1 to 14.6, p<0.0001) and average skin condition was significantly better in the intervention group when compared with controls. There was no significant impact on duration of hospitalisation or neonatal mortality. No adverse effects such as local irritation or local infection were observed among newborns receiving coconut oil applications.

CONCLUSIONS

Topical emollient therapy was effective in maintaining skin integrity and reducing the risk of bloodstream infection in preterm infants in a tertiary hospital setting in Pakistan. The effectiveness of this approach in primary care settings needs to be further explored.

TRIAL REGISTRATION NUMBER

NCT01396642.