Table 2.
Primary, Secondary, and Safety Outcomes.
| Outcome | Unadjusted Analysis (95% CI)* | Adjusted Analysis (95% CI)† | ||||
|---|---|---|---|---|---|---|
| Usual Care | Eat, Sleep, Console |
Usual Care | Eat, Sleep, Console |
Absolute Difference |
Estimated Effect |
|
| Primary outcome | ||||||
| Mean time until medical readiness for discharge — days‡ | 15.3 (13.3 to 17.3) |
8.0 (7.0 to 9.0) |
14.9 (13.1 to 16.7) |
8.2 (7.2 to 9.2) |
6.7 (4.7 to 8.8) |
Rate ratio, 0.55 (0.46 to 0.65) |
| Secondary outcomes | ||||||
| Mean length of hospital stay — days§ | 13.9 (12.5 to 15.3) |
7.8 (7.0 to 8.5) |
14.0 (12.7 to 15.3) |
7.8 (7.1 to 8.5) |
6.2 (4.6 to 7.7) |
Rate ratio, 0.56 (0.49 to 0.64) |
| Percent who received pharmacologic therapy§ | 53.6 (45.9 to 61.3) |
19.2 (14.0 to 24.4) |
52.0 (45.4 to 58.7) |
19.5 (14.9 to 24.2) |
32.5 (25.9 to 39.0) |
Relative risk, 0.38 (0.30 to 0.47) |
| Mean time until initiation ofopioid replacement — hr¶ | 53.0 (49.1 to 56.8) |
71.4 (61.5 to 81.3) |
53.0 (48.7 to 57.3) |
76.0 (63.0 to 89.0) |
23.0 (8.1 to 37.9) |
Rate ratio, 1.43 (1.16 to 1.77) |
| Percent who received adjuvant therapy || | 21.6 (9.3 to 33.9) |
15.6 (5.8 to 25.3) |
19.4 (8.5 to 30.4) |
15.7 (5.5 to 25.8) |
3.7 (−9.8 to 17.3) |
Relative risk, 0.81 (0.37 to 1.76) |
| Total opioid dose before discharge — mg/kg¶ | 6.9 (4.7 to 9.1) |
5.2 (3.2 to 7.2) |
7.5 (5.0 to 10.1) |
5.3 (3.2 to 7.4) |
2.3 (−0.4 to 4.9) |
Rate ratio, 0.70 (0.46 to 1.06) |
| Maximum percentage weight loss — %§ | 7.5 (7.1 to 7.9) |
8.0 (7.5 to 8.4) |
7.6 (7.2 to 8.0) |
8.0 (7.5 to 8.4) |
0.4 (−0.3 to 1.0) |
NA** |
| Feeding type at discharge —%†† | ||||||
| Exclusive maternal breast milk | 6.6 (2.8 to 10.4) |
13.9 (7.7 to 20.1) |
6.3 (2.7 to 9.8) |
12.1 (7.2 to 17.1) |
5.9 (−0.4 to 12.1) |
Relative risk, 1.94 (0.94 to 3.99) |
| Combination offormula and maternal breast milk | 25.6 (18.4 to 32.9) |
32.1 (23.6 to 40.5) |
26.5 (18.7 to 34.2) |
31.3 (23.6 to 39.0) |
4.8 (−8.3 to 17.9) |
Relative risk, 1.18 (0.75 to 1.87) |
| Exclusive formula | 69.9 (61.4 to 78.4) |
58.2 (50.6 to 65.8) |
68.3 (62.2 to 74.4) |
60.0 (53.2 to 66.8) |
8.2 (−1.9 to 18.4) |
Relative risk, 0.88 (0.75 to 1.03) |
| Any direct breast-feeding at discharge (%)†† | 19.1 (15.2 to 22.9) |
35.3 (24.5 to 46.2) |
19.5 (15.3 to 23.7) |
32.7 (23.2 to 42.2) |
13.2 (2.1 to 24.2) |
Relative risk, 1.68 (1.13 to 2.48) |
| Safety outcome | ||||||
| Composite safety outcome at 3-mo follow-up — %‡‡ | 15.5 (12.8 to 18.3) |
15.0 (10.9 to 19.0) |
15.8 (12.3 to 19.2) |
16.1 (11.6 to 20.5) |
0.3 (−6.2 to 5.5) |
Relative risk, 1.02 (0.71 to 1.47) |
The unadjusted analysis does not include demographic covariates. However, it still accounts for the trial design (i.e., a fixed effect for trial period and random site effect) and randomization stratification indicator (proportion of infants who were treated pharmacologically at each site according to lowest third, middle third, and highest third).
The model was adjusted for sex, birth weight, gestational age, gravidity, parity, race, adequate prenatal care, medication for opioid use disorder, polysubstance exposures, and rural-urban commuting area code, in addition to the trial design and randomization stratification indicator.
For the primary outcome, the unadjusted analysis included 837 infants. Because of missing data regarding demographic characteristics (4.7%), the adjusted analysis included 798 infants (P<0.001).
The unadjusted analysis included 1305 infants. Because of missing data regarding demographic characteristics (5.9%), the adjusted analysis included 1228 infants.
The unadjusted analysis included 468 infants who received pharmacologic therapy and were not enrolled in other ACT NOW clinical trials. Because of missing data regarding demographic characteristics (7.5%), the adjusted analysis included 433 infants.
This category is reported as the estimated probability of receipt of adjuvant therapy among infants who received pharmacologic therapy.
NA denotes not available because a linear mixed-effects model was used, so only absolute difference could be calculated.
The type of feeding at discharge is reported as the estimated probability of the outcome. Because of missing data regarding the feeding plan (0.15%), the unadjusted analysis included 1303 infants. Because of missing demographic data (5.8%), the adjusted analysis included 1227 infants.
The composite safety outcome was defined as having an acute or urgent care visit, emergency department visit, or hospitalization during the first 3 months of follow-up. The unadjusted analysis included 1305 infants. Because of missing demographic data (5.9%), the adjusted analysis included 1228 infants.