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Hypothalamic Dysregulation and Oral Feeding in Neonates with Prenatal Drug Exposure

Title Hypothalamic Dysregulation and Oral Feeding in Neonates with Prenatal Drug Exposure
Therapeutic Area Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Principal Investigator Elizabeth Yen, MD
Min Age 0 Years
Gender Any
Contact Kiran Singh and Giselle Castro


This pilot study is aimed at furthering our understanding of prototypical feeding behaviors in newborns born to mothers who used opiates and/or cannabinoids during pregnancy. It is well known that infants born drug-exposed may struggle with their oral feeding skills or may consume 20-40% more calories per day than infants who were not drug exposed during gestation. Our understanding of the molecular mechanisms involved in these feeding behaviors is poorly understood. By comparing the salivary expression of key hypothalamic regulatory genes and/or proteins known to be assoicated with feeding and reward behaviors between drug and non-drug exposed newborns, we hoped to elucidate biological mechanisms responsible for aberrent feeding behaviors.

Study Details

Inclusion Criteria

1. Neonates born between 34 up to 42 weeks’ gestation. 
2. Neonates born to mothers with positive toxicology screen test for opioids and/or THC during her pregnancy or prior to labor.
3. Control subjects will be mothers and their newborns born at Tufts Medical Center, Melrose-Wakefield Hospital, Lowell General Hospital matched for sex and gestational age, who do not have a prenatal history of drug exposure.

Exclusion Criteria

1. Neonates receiving the pharmacological management of NAS. 
2. Infants of diabetic mothers and born in a setting of chorioamnionitis.
3. Infants with congenital and central nervous system anomalies.

Study Requirements

A very small amount of saliva (spit) will be gently suctioned from the infant's mouth or collected using a sponge device. Saliva samples will be collected soon after birth and at various time intervals throughout the hospital stay (e.g., after start of any prescribed medications, following decreasing medications dose and with stopping of medication) and possibly after the discharge from the hospital. 

Post-discharge saliva collection may occur if the infant is followed up at Tufts Pediatric Clinic, and during  routine health checkup appointments up to 18 months of age. Saliva samples will be taken before/after feeding. Alternatively, if the infant is not followed up at Tufts Pediatric Clinic, a saliva collection kit and instructions on how to collect the saliva will be mailed to the subject.

In addition to saliva, upon consent, a lipid panel will be added to the routine blood draw (1 mL or one-fifth of a teaspoon) that the subject's pediatricians will obtain by 12 months of age to evaluate for anemia and lead level.

Brain imaging (magnetic resonance imaging/MRI) will be done shortly after feeding in infants with in utero drug exposure as well as in the sex- and age-matched controls while they are inpatient.
The length of MRI study will be around 30-45 minutes in total. Another MRI will also be done at approximately 2 months of age, upon consent.

Subjects will complete three developmental questionnaires at 6-, 12-, and 18-months of age, upon consent.