Trial Outcomes & Findings for A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants (NCT NCT04419857)
NCT ID: NCT04419857
Last Updated: 2026-06-30
Results Overview
this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
2 weeks
Results posted on
2026-06-30
Participant Flow
39 participants were consented with 4 participants withdrawn prior to randomization. 35 participants were randomized.
Participant milestones
| Measure |
Standard Calorie Formula
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Out of the number of participants taking each drug.
Baseline characteristics by cohort
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.4 weeks
STANDARD_DEVIATION 1.2 • n=16 Participants
|
38.9 weeks
STANDARD_DEVIATION 1.6 • n=19 Participants
|
39.1 weeks
STANDARD_DEVIATION 1.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=16 Participants
|
11 Participants
n=19 Participants
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=16 Participants
|
8 Participants
n=19 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=16 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=16 Participants
|
17 Participants
n=19 Participants
|
33 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=16 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=16 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=16 Participants
|
16 Participants
n=19 Participants
|
31 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=35 Participants
|
|
Birth weight
|
3.0 kilograms
STANDARD_DEVIATION 0.4 • n=16 Participants
|
2.9 kilograms
STANDARD_DEVIATION 0.5 • n=19 Participants
|
3.0 kilograms
STANDARD_DEVIATION 0.5 • n=35 Participants
|
|
Head Circumference
|
33.2 centimeters
STANDARD_DEVIATION 1.6 • n=16 Participants
|
32.9 centimeters
STANDARD_DEVIATION 2.3 • n=19 Participants
|
33.0 centimeters
STANDARD_DEVIATION 2.0 • n=35 Participants
|
|
Gestational Age
|
39.4 weeks
STANDARD_DEVIATION 1.2 • n=16 Participants
|
38.9 weeks
STANDARD_DEVIATION 1.6 • n=19 Participants
|
39.1 weeks
STANDARD_DEVIATION 1.4 • n=35 Participants
|
|
Delivery, Vaginal
|
11 Participants
n=16 Participants
|
11 Participants
n=19 Participants
|
22 Participants
n=35 Participants
|
|
Mother's Age
|
33.4 years
STANDARD_DEVIATION 4.4 • n=16 Participants
|
32.8 years
STANDARD_DEVIATION 4.8 • n=19 Participants
|
33.1 years
STANDARD_DEVIATION 4.5 • n=35 Participants
|
|
Maternal Gravida
|
3.6 pregnancies
STANDARD_DEVIATION 1.6 • n=16 Participants
|
4.0 pregnancies
STANDARD_DEVIATION 2.1 • n=19 Participants
|
3.8 pregnancies
STANDARD_DEVIATION 1.9 • n=35 Participants
|
|
Public Insurance
|
16 Participants
n=16 Participants
|
17 Participants
n=19 Participants
|
33 Participants
n=35 Participants
|
|
Maternal Opioid
Methadone
|
11 Participants
n=16 Participants
|
14 Participants
n=19 Participants
|
25 Participants
n=35 Participants
|
|
Maternal Opioid
Buprenorphine
|
5 Participants
n=16 Participants
|
5 Participants
n=19 Participants
|
10 Participants
n=35 Participants
|
|
Maternal Opioid Dose
Methadone
|
87.0 milligrams
STANDARD_DEVIATION 43.6 • n=11 Participants • Out of the number of participants taking each drug.
|
79.4 milligrams
STANDARD_DEVIATION 40.0 • n=14 Participants • Out of the number of participants taking each drug.
|
82.7 milligrams
STANDARD_DEVIATION 40.3 • n=25 Participants • Out of the number of participants taking each drug.
|
|
Maternal Opioid Dose
Buprenorphine
|
10.0 milligrams
STANDARD_DEVIATION 8.3 • n=5 Participants • Out of the number of participants taking each drug.
|
10.4 milligrams
STANDARD_DEVIATION 7.8 • n=5 Participants • Out of the number of participants taking each drug.
|
10.2 milligrams
STANDARD_DEVIATION 7.6 • n=10 Participants • Out of the number of participants taking each drug.
|
|
Poly-opioid Use
|
3 Participants
n=16 Participants
|
4 Participants
n=19 Participants
|
7 Participants
n=35 Participants
|
|
Polysubstance Use
|
7 Participants
n=16 Participants
|
8 Participants
n=19 Participants
|
15 Participants
n=35 Participants
|
|
Caregiver Current Smoker
|
10 Participants
n=16 Participants
|
14 Participants
n=19 Participants
|
24 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 weeksthis will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight
Outcome measures
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Maximal Percent Weight Loss Compared to Birth Weight
|
-5.4 percent weight loss
Interval -7.7 to -4.0
|
-9.1 percent weight loss
Interval -10.4 to -8.2
|
SECONDARY outcome
Timeframe: 2 weeksMeasured by determining the days of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth
Outcome measures
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Median Days to Weight Nadir
|
3.5 days
Interval 2.0 to 5.0
|
4.0 days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 monthNumber of participants that regained birthweight, assessed within the first month after birth
Outcome measures
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Number of Participants That Return to Birthweight
Yes
|
8 Participants
|
9 Participants
|
|
Number of Participants That Return to Birthweight
No
|
3 Participants
|
7 Participants
|
|
Number of Participants That Return to Birthweight
Unknown
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: first 7 days after birthMeasured by comparing the weight from the weight obtained the day prior, assessed daily for the first 7 days after birth
Outcome measures
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Percent Weight Change Per Day
Day 4
|
-5.7 percentage weight change
Standard Deviation 3.0
|
-8.70 percentage weight change
Standard Deviation 2.50
|
|
Percent Weight Change Per Day
Day 5
|
-5.67 percentage weight change
Standard Deviation 3.65
|
-8.17 percentage weight change
Standard Deviation 3.02
|
|
Percent Weight Change Per Day
Day 6
|
-5.29 percentage weight change
Standard Deviation 5.01
|
-7.00 percentage weight change
Standard Deviation 2.85
|
|
Percent Weight Change Per Day
Day 7
|
-2.34 percentage weight change
Standard Deviation 9.48
|
-5.94 percentage weight change
Standard Deviation 3.27
|
|
Percent Weight Change Per Day
Day 1
|
-1.43 percentage weight change
Standard Deviation 1.95
|
-2.76 percentage weight change
Standard Deviation 2.16
|
|
Percent Weight Change Per Day
Day 2
|
-4.85 percentage weight change
Standard Deviation 1.99
|
-6.50 percentage weight change
Standard Deviation 3.5
|
|
Percent Weight Change Per Day
Day 3
|
-4.99 percentage weight change
Standard Deviation 3.2
|
-8.52 percentage weight change
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: up to 6.5 daysMeasured by comparing admission time to discharge time, assessed at hospital discharge
Outcome measures
| Measure |
Standard Calorie Formula
n=16 Participants
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 Participants
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Length of Hospital Stay
|
4.4 days
Standard Deviation 2.5
|
4.1 days
Standard Deviation 1.4
|
Adverse Events
Standard Calorie Formula
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High-calorie Formula
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Calorie Formula
n=16 participants at risk
Infant randomly assigned to standard-calorie formula for 14 days
|
High-calorie Formula
n=19 participants at risk
Infant randomly assigned to high-calorie formula for 14 days
|
|---|---|---|
|
Metabolism and nutrition disorders
Weight loss
|
6.2%
1/16 • 1 month
|
15.8%
3/19 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place