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Table 4 Intention-to-treat evaluation of infant outcomes by intervention group

From: Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs

Outcome

FCC

(n = 141)

mFICare

(n = 112)

   

Primary: Weight gain

Mean (SD) {n}

Mean (SD) {n}

p -value a

Adjusted difference c (95% CI) {n}

p -value

Change in weight z-score from study day 1 to 22

-0.028 (0.341) {124}b

-0.002 (0.449) {100}b

0.40

-0.023 (-0.082, 0.036) {250}

0.45

Secondary: Morbidities and feeding

% (n)

% (n)

 

Adjusted OR d−g (95% CI) {n}

 

Nosocomial infection

14.9% (21)

7.1% (8)

0.055

2.6 (1.0, 6.7) {253}

0.049

Bronchopulmonary dysplasia (BPD)

21.6% (30)

24.1% (27)

0.64

0.5 (0.2, 1.2) {249}

0.15

Retinopathy of prematurity (ROP)

34.8% (49)

33.0% (37)

0.78

1.5 (0.7, 3.1) {253}

0.42

No human milk feeding at discharge

64.3% (90)

56.3% (63)

0.19

1.5 (0.9, 2.6) {243}

0.28

  1. P-values < 0.05 are in bold. mFICare is the reference group for regression analyses. Odds ratios (OR) < 1 indicate better outcomes in the FCC group than in the mFICare group; ORs > 1 indicate worse outcomes in the FCC group
  2. aP-values for unadjusted comparisons of change in weight z-scores (Mann-Whitney U tests) and morbidity and feeding outcomes (chi-square tests) by intervention group
  3. bSample size is limited to the 224 infants with weight z-scores s at both study day 1 and 22. Negative z-score changes indicate that infant weight had a decreasing percentile rank over time (i.e., weight gain was slower than preterm infant growth norms)
  4. cWeight gain model (mixed linear) adjusts for site, gestational age at birth, small for gestational age, necrotizing enterocolitis, and morbidity count (a proxy of clinical course complexity, defined as the total of five common preterm morbidities during the NICU stay [nosocomial infection, BPD, ROP, necrotizing enterocolitis, and intraventricular hemorrhage], trichotomized as 0, 1 or 2–5). Negative difference indicates that FCC group gained less weight than the mFICare group
  5. dInfection model (logistic) adjusts for site, gestational age at birth, and any ventilation
  6. eBPD model (logistic) adjusts for site, gestational age at birth, and any surgery
  7. fROP model (logistic) adjusts for site, gestational age at birth, and small for gestational age
  8. gHuman milk feeding model (logistic) adjusts for site, gestational age at birth, Hispanic ethnicity, and BPD
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BMC Pediatrics

ISSN: 1471-2431

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