title: Evaluation of the uptake and impact of neonatal vitamin A supplementation delivered through the Lady Health Worker programme on neonatal and infant morbidity and mortality in rural Pakistan: an effectiveness trial.
abstract: BACKGROUND
  Despite evidence for the benefits of vitamin A supplementation (VAS) among children 6 to 59 months of age, the feasibility of introduction and potential benefit of VAS in the neonatal period in public health programmes is uncertain.
  
  
  OBJECTIVE
  The primary objective was to evaluate the feasibility and effectiveness of early neonatal VAS (single dose of 50 000 international units within 48-72 hours after birth) delivered through the public sector Lady Health Worker (LHW) programme in rural Pakistan and to document its association with a reduction in mortality at 6 months of age.
  
  
  METHODS
  A community-based, cluster randomised, placebo-controlled trial was undertaken in two districts of rural Pakistan. LHWs dispensed vitamin A/placebo in identical capsules to newborn infants within 48-72 hours of birth. Follow-up visits were undertaken at 1 week of age and every 4 weeks thereafter until 6 months of age.
  
  
  RESULTS
  Of a total of 15 433 consecutive pregnancies among eligible women of reproductive age, 13 225 pregnancies were registered, 12 218 live births identified and 11 028 newborn infants reached by LHWs. Of these, 5380 (49%) received neonatal VAS and 5648 (51%) placebo. The LHWs successfully delivered the capsules to 79% of newborns within 72 hours of birth with no significant adverse effects. Although the proportion of days observed with symptoms of fever, diarrhoea or rapid breathing were lower with neonatal VAS, these differences were not statistically significant. Mortality rates in the two groups were comparable at 6 months of age.
  
  
  CONCLUSIONS
  While our study demonstrated that neonatal VAS was safe and could be feasibly delivered by LHWs in Pakistan as part of their early postnatal visits, the overall lack of benefit on neonatal and 6-month morbidity and mortality in our population suggests the need for further evaluation of this intervention in populations at risk.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00674089.
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Sajid
authors.initials: S
authors.lastname: Soofi
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Shabina
authors.initials: S
authors.lastname: Ariff
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Kamran
authors.initials: K
authors.lastname: Sadiq
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Atif
authors.initials: A
authors.lastname: Habib
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Zaid
authors.initials: Z
authors.lastname: Bhatti
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Imran
authors.initials: I
authors.lastname: Ahmad
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.
authors.forename: Masawar
authors.initials: M
authors.lastname: Hussain
authors.affiliation: John Snow International Research Institute, Islamabad, Pakistan.
authors.forename: Nabeela
authors.initials: N
authors.lastname: Ali
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Cousens
authors.affiliation: Women & Child Health Division, The Aga Khan University, Karachi, Pakistan.|London School of Hygiene and Tropical Medicine, London, UK.|Centre for Global Child Health, The Hospital for Sick Children, Toronto, UK.
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
mesh_terms: D000293:Adolescent; D000328:Adult; D002214:Capsules; D003430:Cross-Sectional Studies; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D010154:Pakistan / Q000453:epidemiology; D012423:Rural Health; D012959:Socioeconomic Factors; D014801:Vitamin A / Q000008:administration & dosage* / Q000097:blood; D014802:Vitamin A Deficiency / Q000178:diet therapy* / Q000401:mortality; D014815:Vitamins / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D002214:Capsules; D014815:Vitamins; D014801:Vitamin A
keywords: Lady Health Worker; Neonatal Morbidity; Neonatal Mortality; Vitamin A Supplementation