Back to resultsA Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Primary Purpose
Neonatal Abstinence Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-calorie formula
Sponsored by
About this trial
This is an interventional supportive care trial for Neonatal Abstinence Syndrome focused on measuring high-caloric diet regimens
Eligibility 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
Sites / Locations
- Yale New Haven HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High-calorie formula
Standard calorie formula
Arm Description
Infant randomly assigned to high-calorie formula for 14 days
Infant randomly assigned to standard-calorie formula for 14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Hours to weight nadir
Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth
Days to return to birthweight
Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth
Percent weight change per day
Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth
Length of hospital stay
Measured by comparing admission time to discharge time, assessed at hospital discharge
Full Information
NCT ID
NCT04419857
First Posted
June 3, 2020
Last Updated
April 25, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04419857
Brief Title
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Official Title
A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
high-caloric diet regimens
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-calorie formula
Arm Type
Experimental
Arm Description
Infant randomly assigned to high-calorie formula for 14 days
Arm Title
Standard calorie formula
Arm Type
No Intervention
Arm Description
Infant randomly assigned to standard-calorie formula for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
High-calorie formula
Intervention Description
Infant randomly assigned to high-calorie formula for 14 days
Primary Outcome Measure Information:
Title
Maximal percent weight loss compared to birth weight
Description
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
Secondary Outcome Measure Information:
Title
Hours to weight nadir
Description
Measured by determining the hours 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
Title
Days to return to birthweight
Description
Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth
Time Frame
1 month
Title
Percent weight change per day
Description
Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth
Time Frame
2 weeks
Title
Length of hospital stay
Description
Measured by comparing admission time to discharge time, assessed at hospital discharge
Time Frame
up to 6.5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Palmieri, BA
Phone
203-785-4651
Email
lisa.palmieri@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Grossman, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Grossman, MD
First Name & Middle Initial & Last Name & Degree
Francis Cheng, MD
Email
frances.cheng@yale.edu
First Name & Middle Initial & Last Name & Degree
Matthew Grossman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
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