Skip to main content
. 2019 Jul 17;2019(7):CD004204. doi: 10.1002/14651858.CD004204.pub3

Kashyap 1986.

Methods Randomised controlled trial
Participants Preterm infants of birth weight 900 to 1750 g (excluding infants with gastrointestinal tract, renal, or respiratory problems)
Interventions Sole diet:
Nutrient‐enriched formula (N = 11)
  • Energy (kcal/100 mL): 82.4

  • Protein (g/100 mL): 1.98

  • Target intake (mL/kg/d): 180


Standard formula (N = 12)
  • Energy (kcal/100 mL): 62.5

  • Protein (g/100 mL): 1.26

  • Target intake (mL/kg/d): 180

Outcomes Time to regain birth weight
Rate of weight, length, and head circumference gain
Rate of skinfold thickness gain ‐ triceps and subscapular
Identification Sponsorship source: US National Institute of Health Research grants (HD13020, AM27358, RR00645); Bristol‐Myers Grant
Setting: Department of Pediatrics, Columbia University College of Physicians & Surgeons, USA (early 1980s)
Notes Infants were randomised into 3 groups. Only data from group 1 ("standard formula") and group 3 ("nutrient‐enriched formula") were included in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "...assigned randomly shortly after birth to receive one of three formulas" ‐ sequence generation not described.
Allocation concealment (selection bias) Low risk Allocated colour‐coded formula ‐ investigators and nurses did not know how the codes applied to the formulas
Blinding (performance bias and detection bias) 
 All outcomes Low risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Formula containers were colour coded, with code known to neither the investigator nor nurses caring for the infants
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcome assessments likely to include complete cohort
Selective reporting (reporting bias) Low risk A trial protocol could not be found, but data for all outcomes described in the methods section of the paper were reported in the results
Other bias Unclear risk The study was funded by a pharmaceutical company. It is unclear if this company was also the manufacturer of the formulas used in the study
Infants in the standard formula group had slightly higher mean birth weight