title: Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding.
abstract: OBJECTIVE
  Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age.
  
  
  METHODS
  We randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF) intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation) or control group (standard approach, SA). Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing).
  
  
  RESULTS
  Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively), 3 months (p-value 0.12 and 0.10) and 6 months of infants' age (p-value 0.45 and 0.34 respectively). The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002).
  
  
  CONCLUSIONS
  The study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall.
  
  
  BACKGROUND
  ISRCTN registry ISRCTN61915183.
authors.affiliation: Third Faculty of Medicine, Charles University, Prague, Czech Republic.|Department of Neonatology, Institute for the Care of Mother and Child, Prague, Czech Republic.
authors.forename: Zbyněk
authors.initials: Z
authors.lastname: Straňák
authors.affiliation: Department of Neonatology, Institute for the Care of Mother and Child, Prague, Czech Republic.
authors.forename: Simona
authors.initials: S
authors.lastname: Feyereislova
authors.affiliation: Department of Neonatology, Institute for the Care of Mother and Child, Prague, Czech Republic.
authors.forename: Marcela
authors.initials: M
authors.lastname: Černá
authors.affiliation: Department of Neonatology, Institute for the Care of Mother and Child, Prague, Czech Republic.
authors.forename: Jana
authors.initials: J
authors.lastname: Kollárová
authors.affiliation: Department of Obstetrics and Gynecology, Institute for the Care of Mother and Child, Prague, Czech Republic.
authors.forename: Jaroslav
authors.initials: J
authors.lastname: Feyereisl
mesh_terms: D000328:Adult; D000367:Age Factors; D001724:Birth Weight / Q000187:drug effects / Q000502:physiology*; D001835:Body Weight / Q000187:drug effects / Q000502:physiology*; D001942:Breast Feeding / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage*; D007227:Infant Nutritional Physiological Phenomena / Q000502:physiology*; D007231:Infant, Newborn; D008297:Male