Table 6.

Pediatric Outcomes Between Randomization and Three Months' Corrected Age*

Conventional
n = 325
Supplemental
n = 324
Event occurring after randomization
 Weight gain over the first 2 wk (g; mean ± standard deviation)291  ± 137278  ± 143
 Length gain over the first 2 wk (cm; mean ± standard deviation)1.8  ± 1.81.7  ± 2.0
 Head circumference increase the 1st 2 wk (cm; mean ± standard deviation)1.6  ± 1.01.4  ± .9
 PMA at discharge home (wk; mean ± standard deviation)41.1  ± 3.341.3  ± 3.4
 PMA to achieve oral feeding (wk; mean ± standard deviation)39.0  ± 3.538.9  ± 3.6
 Infants with pneumonia/CLD events (total # of events)§25  (29)38  (51)
 Infants with sepsis, but no pneumonia/CLD (total #events)12  (12)11  (11)
 Infants with apnea/bradys triple baseline (total # events)26  (36)30  (33)
Outcomes at the 3-month corrected age window
 Remained hospitalized(%)6.8%12.7%
 Remained on study equipment (%)3.1%3.4%
 Remained on oxygen (%)37.3%46.8%
 Remained on steroids (%)12.5%14.2%
 Remained on methylxanthines (%)13.5%14.7%
 Remained on diuretics (%)24.4%35.8%
 Infants with any 1 of the above, # of infants (%)#148  (45.5%)183  (56.5%)
Outcomes at 3 months' corrected age examinationn  = 301n  = 302
 Infants rehospitalized (# of all rehospitalizations)99  (132)87  (116)
 Infants rehospitalized for pulmonary reasons, not apnea (# of all
 rehospitalizations)
46  (53)41  (49)
 All deaths, n (pulmonary cause of death,n)7  (3)9  (5)
 Room air saturations too low to test, n (%)17  (6%)35  (12%)
 Room air oxygen saturation for those tested, mean ± standard deviation95.3  ± 4.7%94.6  ± 7.7%
 Weight gain from randomization (mean ± standard deviation; kg)2.96  ± 1.002.88  ± 1.05
 R-PDQ developmental level** (mean ± standard deviation; mo)3.5  ± 1.43.4  ± 1.4
  • * Corrected age indicates months after the date an infant should have been born at full term (3 months' corrected = 52 weeks' PMA).

  • Limited to infants who were discharged to home (ie, excludes deaths, loss to follow-up, and those remaining hospitalized at the 3-month examination).

  • Excludes 16 conventional and 33 supplemental infants who were not yet feeding by mouth by 50 weeks' PMA, 2 conventional and 7 supplemental infants who died before oral feeds, and 6 conventional and 7 supplemental infants with incomplete data. Oral feeds means that the infant was taking all enteral feedings by nipple (bottle or breast).

  • § Excludes 30 conventional and 36 supplemental infants recruited early in the trial for whom these data were not collected.

  • The 3-month corrected age window was a target of 12 ± 2 weeks after due date, or 50 to 54 weeks' PMA. Outcomes are reported as of 50 weeks' PMA to permit comparisons as some infants were examined late in the window or outside this window.

  • Values exclude 31 infants with missing data at 50 weeks' PMA attributable to loss to follow-up (14 conventional and 17 supplemental).

  • # Number of infants, and percent of all enrollees represented by any 1 or more of the 3-month events.

  • ** R-PDQ indicates the Revised Parental Denver Questionnaire.26