title: Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial.
abstract: Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation.
  
  
  
  In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31-33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ12) based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149.
  
  
  
  Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ12between two groups: -1·6 (SD 1·2) in the 4 month group versus -1·6 (SD 1·3) in the 6 month group (mean difference 0·005, 95% CI -0·24 to 0·25; p=0·965). There were more hospital admissions in the 4 month group compared with the 6 month group: 2·5 episodes per 100 infant-months in the 4 month group versus 1·4 episodes per 100 infant-months in the 6 month group (incidence rate ratio 1·8, 95% CI 1·0-3·1, p=0·03). 34 (18%) of 188 infants in the 4 month group required hospital admission, compared with 18 (9%) of 192 infants in the 6 month group.
  
  
  
  Although there was no evidence of effect for the primary endpoint of WAZ12, the higher rate of hospital admission in the 4 month group suggests a recommendation to initiate complementary feeding at 6 months over 4 months of corrected age in infants less than 34 weeks of gestation.
  
  
  
  Indian Council of Medical Research supported the study until Nov 14, 2015. Subsequently, Shuchita Gupta's salary was supported for 2 months by an institute fellowship from All India Institute Of Medical Sciences, and a grant by Wellcome Trust thereafter.
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Shuchita
authors.initials: S
authors.lastname: Gupta
authors.affiliation: All India Institute of Medical Sciences, Delhi, India. Electronic address: ra.aiims@gmail.com.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: Vardhman Mahavir Medical College and associated Safdarjung hospital, New Delhi, India.
authors.forename: Kailash Chandra
authors.initials: KC
authors.lastname: Aggarwal
authors.affiliation: Vardhman Mahavir Medical College and associated Safdarjung hospital, New Delhi, India.
authors.forename: Harish
authors.initials: H
authors.lastname: Chellani
authors.affiliation: All India Institute of Medical Sciences, Delhi, India; Kasturba Hospital, Delhi, India.
authors.forename: Anil
authors.initials: A
authors.lastname: Duggal
authors.affiliation: Vardhman Mahavir Medical College and associated Safdarjung hospital, New Delhi, India.
authors.forename: Sugandha
authors.initials: S
authors.lastname: Arya
authors.affiliation: All India Institute of Medical Sciences, Delhi, India; Kasturba Hospital, Delhi, India.
authors.forename: Sunita
authors.initials: S
authors.lastname: Bhatia
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Mari Jeeva
authors.initials: MJ
authors.lastname: Sankar
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Vishnubhatla
authors.initials: V
authors.lastname: Sreenivas
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Vandana
authors.initials: V
authors.lastname: Jain
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Arun Kumar
authors.initials: AK
authors.lastname: Gupta
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Ashok K
authors.initials: AK
authors.lastname: Deorari
authors.affiliation: All India Institute of Medical Sciences, Delhi, India.
authors.forename: Vinod K
authors.initials: VK
authors.lastname: Paul
mesh_terms: D000328:Adult; D000818:Animals; D001835:Body Weight; D001942:Breast Feeding; D005260:Female; D005865:Gestational Age; D006760:Hospitalization; D006801:Humans; D007194:India; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007234:Infant, Premature / Q000254:growth & development*; D008297:Male; D008892:Milk; D013997:Time Factors; D055815:Young Adult