Neonatal Abstinence SyndromeNCT04419857
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A study testing High-calorie formula in people with Neonatal Abstinence Syndrome, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- High-calorie formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 1 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Infant Inclusion Criteria:
- Infants with NAS born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption
- Infants > 2200 g Infants at least 36 weeks gestational age
- Delivered at: Yale New Haven Hospital
- Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits
Infant Exclusion Criteria:
- Infants with major congenital malformations
- Infants enrolled to NICU >24 hours for medical conditions other than NAS treatment before 3 days of life
Mother's Inclusion criteria -
- Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
- Confirm methadone treatment is received from a licensed treatment program
- Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
- Confirm that mothers do not intend to place the infant(s) for adoption
- Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
- Consent forms will be signed and faxed to study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
Official title: A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
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.
Read the detailed description
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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- High-calorie formula
- Keywords
- high-caloric diet regimens
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-calorie formulaDietary supplement
Infant randomly assigned to high-calorie formula for 14 days
| Study group | Role | What they receive |
|---|---|---|
| High-calorie formula | Experimental | Infant randomly assigned to high-calorie formula for 14 days Receives: Dietary Supplement: High-calorie formula |
| Standard calorie formula | No intervention | Infant randomly assigned to standard-calorie formula for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (4)
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
Measured: 2 weeks
Number of Participants That Return to Birthweight
Number of participants that regained birthweight, assessed within the first month after birth
Measured: 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
Measured: first 7 days after birth
Length of Hospital Stay
Measured by comparing admission time to discharge time, assessed at hospital discharge
Measured: up to 6.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start4 Dec 2020
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Grossman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419857
- Sponsor's protocol ID
- 2000028252
- Other IDs
- 2T35DK104689-06
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2020
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
- ClinicalTrials.gov ID
- NCT04419857
- Acronym / sponsor ID
- 2000028252
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- high-caloric diet regimens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-calorie formula | Experimental | Dietary Supplement: High-calorie formulaInfant randomly assigned to high-calorie formula for 14 days |
| Standard calorie formula | No intervention | –Infant randomly assigned to standard-calorie formula for 14 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-calorie formulaInfant randomly assigned to high-calorie formula for 14 days | Dietary supplement | High-calorie formula |
Primary outcome
Maximal Percent Weight Loss Compared to Birth Weight
Time frame: 2 weeks
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
4 secondary outcomes
Median Days to Weight Nadir
Time frame: 2 weeks
Number of Participants That Return to Birthweight
Time frame: 1 month
Percent Weight Change Per Day
Time frame: first 7 days after birth
Length of Hospital Stay
Time frame: up to 6.5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Grossman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-calorie formula in people with Neonatal Abstinence Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Percent Weight Loss Compared to Birth Weight (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.