An interventional study of High-calorie formula in Neonatal Abstinence Syndrome, sponsored by Yale University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
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Among 59 studies in Neonatal Abstinence Syndrome with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Neonatal Abstinence Syndrome · United States.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, this one is the 27th largest by enrollment of the 47 interventional ones that give a count, is one of 9 that started in 2020, is one of 21 with no phase, and was the 50th registered.
68 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
Browse Neonatal Abstinence Syndrome studies →4 of the 59 studies in Neonatal Abstinence Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
Milton S. Hershey Medical Center · Sites in United States
Ages 1 days–5 days
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 28 wk+
Rekovar Inc. · Sites in United States
Ages up to 4 wk · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Neonatal Abstinence Syndrome studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 12 · Phase 3 10 · Phase 4 6
First in 2002; this study’s year is marked. 9 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 39 is below the median of 48 across 52 interventional studies indexed under Neonatal Abstinence Syndrome.
Median enrollment 42 across the 47 interventional studies, 58 across the 12 observational. Of the 50 that completed or were terminated, 26 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 59 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,772 studies on the registry; 296 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 1 study filed under Neonatal Abstinence Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Neonatal Abstinence Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05937594Milton S. Hershey Medical CenterMicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome | 2026-12-10 |
| NCT03533985Icahn School of Medicine at Mount SinaiEffect of Music Therapy on Infants With Neonatal Abstinence Syndrome | 2026-12-31 |
| NCT06576323University of PennsylvaniaAn Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT) | 2027-05-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though women who are not adherent to drug treatment programs or have the potential to use illicit drugs are not able to breastfeed due to the risks posed to the infant. Several studies have demonstrated the potential for caloric enhancement of formula and breast milk to support weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS infants and show that increasing caloric intake can improve weight gain.
Infant Inclusion Criteria:
Infant Exclusion Criteria:
Mother's Inclusion criteria -
Infant randomly assigned to high-calorie formula for 14 days
Dietary Supplement: High-calorie formula
Infant randomly assigned to standard-calorie formula for 14 days
Infant randomly assigned to high-calorie formula for 14 days
Maximal Percent Weight Loss Compared to Birth Weight
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
Time frame: 2 weeks
Median Days to Weight Nadir
Measured 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
Time frame: 2 weeks
Number of Participants That Return to Birthweight
Number of participants that regained birthweight, assessed within the first month after birth
Time frame: 1 month
Percent Weight Change Per Day
Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first 7 days after birth
Time frame: first 7 days after birth
Length of Hospital Stay
Measured by comparing admission time to discharge time, assessed at hospital discharge
Time frame: up to 6.5 days
| Milestone | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Started | 16 | 19 |
| Completed | 16 | 19 |
| Not completed | 0 | 0 |
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
| percent weight loss | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Maximal Percent Weight Loss Compared to Birth Weight | -5.4 (-7.7 to -4.0) | -9.1 (-10.4 to -8.2) |
Measured 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
| days | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Median Days to Weight Nadir | 3.5 (2.0 to 5.0) | 4.0 (3.0 to 4.0) |
Number of participants that regained birthweight, assessed within the first month after birth
| Participants | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Yes | 8 | 9 |
| No | 3 | 7 |
| Unknown | 5 | 3 |
Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first 7 days after birth
| percentage weight change | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Day 1 | -1.43 ± 1.95 | -2.76 ± 2.16 |
| Day 2 | -4.85 ± 1.99 | -6.50 ± 3.5 |
| Day 3 | -4.99 ± 3.2 | -8.52 ± 1.92 |
| Day 4 | -5.7 ± 3.0 | -8.70 ± 2.50 |
| Day 5 | -5.67 ± 3.65 | -8.17 ± 3.02 |
| Day 6 | -5.29 ± 5.01 | -7.00 ± 2.85 |
| Day 7 | -2.34 ± 9.48 | -5.94 ± 3.27 |
Measured by comparing admission time to discharge time, assessed at hospital discharge
| days | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Length of Hospital Stay | 4.4 ± 2.5 | 4.1 ± 1.4 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Calorie Formula | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| High-calorie Formula | 0/19 (0%) | 0/19 (0%) | 3/19 (15.8%) |
| Event | Standard Calorie Formula | High-calorie Formula |
|---|---|---|
| Weight lossMetabolism and nutrition disorders | 1/16 | 3/19 |
| Age, Continuous(weeks) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Mean | 39.4 ± 1.2 | 38.9 ± 1.6 | 39.1 ± 1.4 |
| Sex: Female, Male(Participants) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Female | 6 | 11 | 17 |
| Male | 10 | 8 | 18 |
| Race (NIH/OMB)(Participants) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 16 | 17 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 15 | 16 | 31 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Birth weight(kilograms) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Mean | 3.0 ± 0.4 | 2.9 ± 0.5 | 3.0 ± 0.5 |
| Head Circumference(centimeters) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Mean | 33.2 ± 1.6 | 32.9 ± 2.3 | 33.0 ± 2.0 |
| Gestational Age(weeks) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Mean | 39.4 ± 1.2 | 38.9 ± 1.6 | 39.1 ± 1.4 |
| Delivery, Vaginal(Participants) | Standard Calorie Formula | High-calorie Formula | Total |
|---|---|---|---|
| Count of participants | 11 | 11 | 22 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in May 2025, 52 months.
Results were first posted in Jun 2026, 1 year 1 month after primary completion.
Of 18 interventional studies with no phase under Neonatal Abstinence Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 60. This study's 52 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Neonatal Abstinence Syndrome →