Neonatal Abstinence Syndrome
Conditions
Keywords
high-caloric diet regimens
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.
Interventions
DIETARY_SUPPLEMENTHigh-calorie formula
Infant randomly assigned to high-calorie formula for 14 days
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Percent Weight Loss Compared to Birth Weight | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Days to Weight Nadir | 2 weeks | 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 |
| Number of Participants That Return to Birthweight | 1 month | Number of participants that regained birthweight, assessed within the first month after birth |
| Percent Weight Change Per Day | first 7 days after birth | Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first 7 days after birth |
| Length of Hospital Stay | up to 6.5 days | Measured by comparing admission time to discharge time, assessed at hospital discharge |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Grossman, MD
Yale University
Participant flow
Pre-assignment details
39 participants were consented with 4 participants withdrawn prior to randomization. 35 participants were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.1 weeks STANDARD_DEVIATION 1.4 |
| Birth weight | 2.9 kilograms STANDARD_DEVIATION 0.5 |
| Caregiver Current Smoker | 10 Participants |
| Delivery, Vaginal | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Gestational Age | 39.4 weeks STANDARD_DEVIATION 1.2 |
| Head Circumference | 32.9 centimeters STANDARD_DEVIATION 2.3 |
| Maternal Gravida | 4.0 pregnancies STANDARD_DEVIATION 2.1 |
| Maternal Opioid Buprenorphine | 10 Participants |
| Maternal Opioid Methadone | 25 Participants |
| Maternal Opioid Dose Buprenorphine | 10.4 milligrams STANDARD_DEVIATION 7.8 |
| Maternal Opioid Dose Methadone | 82.7 milligrams STANDARD_DEVIATION 40.3 |
| Mother's Age | 33.4 years STANDARD_DEVIATION 4.4 |
| Poly-opioid Use | 4 Participants |
| Polysubstance Use | 15 Participants |
| Public Insurance | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 19 |
| other Total, other adverse events | 1 / 16 | 3 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
None listed