Evaluating weight gain benefits of high-caloric diets for infants with Neonatal Abstinence Syndrome
A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
This study is testing if a high-calorie diet can help newborns with Neonatal Abstinence Syndrome gain weight better than a standard diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04419857 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of high-caloric diet regimens in promoting weight gain in infants diagnosed with Neonatal Abstinence Syndrome (NAS) during their first three weeks of life. The study employs a randomized control design, comparing standard-calorie feeding with high-calorie feeding while utilizing the Eat, Sleep, Console (ESC) approach for managing NAS. The trial focuses on infants born to mothers undergoing methadone treatment, with the goal of quantifying weight patterns and demonstrating that increased caloric intake can enhance weight gain in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are NAS infants born to mothers aged 18-45 who have been treated with methadone and are not planning to place their infants for adoption.
Not a fit: Patients who may not benefit from this study include those with major congenital malformations or who have been in the NICU for more than 24 hours for conditions unrelated to NAS treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved weight gain and overall health outcomes for infants suffering from Neonatal Abstinence Syndrome.
How similar studies have performed: Previous studies have indicated potential benefits of caloric enhancement in formula and breast milk for NAS infants, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Grossman, MD — Yale University
- Study coordinator: Lisa Palmieri, BA
- Email: lisa.palmieri@yale.edu
- Phone: 203-785-4651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.