Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial
Author:
Kumar Vishwajeet1, Kumar Aarti1, Mishra Shambhavi2, Kan Peiyi3, Ashraf Sana1, Singh Shambhavi1, Blanks Keona J H4, Baiocchi Michael5ORCID, Limcaoco Mika6, Ghosh Amit Kumar7, Kumar Alok8, Krishna Raghav1, Stevenson David K3, Tian Lu9, Darmstadt Gary L3ORCID, Ashraf Sana, Darmstadt Gary LORCID, Elias Peter M, Ghosh Amit Kumar, Kan Peiyi, Krishna Raghav, Kumar Aarti, Kumar Alok, Kumar Vishwajeet, Mehrotra Hina, Mishra Shambhavi, Patil Pawankumar, Sahu Arti, Singh Pramod, Singh Shambhavi, Singh Vivek, Stevenson David K, Tian Lu, Yadav Ranjana,
Affiliation:
1. Community Empowerment Lab, Lucknow, Uttar Pradesh, India 2. Department of Statistics, Lucknow University, Lucknow, Uttar Pradesh, India 3. Prematurity Research Center, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA 4. Stanford University, Stanford, CA, USA 5. Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA 6. Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA 7. Government of India 8. Government of Uttar Pradesh 9. Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA
Abstract
Abstract
Background
Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking.
Objective
We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at population-level.
Design
We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis.
Results
We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight by 0.94 grams/kilogram/day (g/kg/d) [95% confidence interval (CI): 0.07, 1.82, p = 0.03] than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g/kg/day) occurred in infants <2000 g. Weight gain in intervention infants was higher by 1.31 g/kg/d (95% CI: 0.17, 2.46, p = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% [odds ratio (OR): 0.64; 95% CI: 0.44, 0.94, p = 0.02] and 44% (OR: 0.56; 95% CI: 0.40, 0.77, p<0.001), respectively, in treated infants.
Conclusions
SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at population-level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings.
Clinical Trial Registry: The trial was registered at the ISRCTN (ISRCTN38965585) and CTRI (CTRI/2014/12/005282) registries with WHO UTN # U1111-1158-4665.
Publisher
Oxford University Press (OUP)
Subject
Nutrition and Dietetics,Medicine (miscellaneous)
Cited by
3 articles.
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