Infants Removed From Assigned Study Formula

No. InfantsDay Study Formula StoppedReason for Removala
High-calorie group (n = 4)
 26, 9Placed on standard-calorie soy formula for maternal concern with milk allergy
 15Placed on standard-calorie soy formula by pediatrician for concern of milk allergy
 16Placed on open-label, high-calorie, cow milk formula for wt loss of 10.3%
Standard-calorie group (n = 6) changed to high-calorie formula
 24, 6Doctors withdrew infants from study and placed on high-calorie, cow milk formula for wt loss of 13.8% (day 4) and 11.5% (day 6)
 111Infant was discharged to foster care. Primary care provider wanted infant on high-calorie formula; weight loss was 3.9%
 112Infant had wt loss of 11.3% at day 12 and slow wt gain from days 6 to 12 (9 g per d)
 114bInfant had wt loss of 6.36% at day 14b
 116bInfant had wt loss of 8.8% at day 16b
Infants lost to follow-up before reaching birth wt or day 21
 High-calorie group (n = 6)
  68, 14, 16, 18(2), 19Lost to follow-up after discharge from the hospital
 Standard calorie group (n = 3)
  2a15, 18Lost to follow-up at discharge from hospital
  19Transfer to pediatric hospital for surgical consult
  • a Infants remained in analyses until they were discharged from the hospital or mothers stopped reporting weights.

  • b Met predetermined criteria of not gaining at least 15 g per day by day 14.