Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
Condition: Narcotic Addiction; Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome; Narcotic-Related Disorders; Behavior, Addictive
Intervention: Ondansetron; Placebo
Intervention description: Pregnant women may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. 50% of the 90 mother/baby pairs will receive ondansetron; the baby will always get the same study medication as the mother.; All doses of placebo, whether IV or oral, will mimic the same volume as the ondansetron group to maintain the blind. Pregnant women may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. 50% of the 90 mother/baby pairs will receive placebo; the baby will always receive the same study medication as the mother.
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Narcotic addiction during pregnancy; Neonatal abstinence syndrome; NAS

Summary:

      The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal
      abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug
      ondansetron in the mothers prior to delivery and their babies after delivery.

      The study is a randomized, double-blind, placebo-controlled study with one half the
      mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to
      receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of
      study medication prior to delivery; the neonates, after their birth, will receive the same
      study medication the mother received every 24 hours for up to 5 days.

      The Investigators will follow up with the mother-baby pairs for 10 days after study drug has
      stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby
      had any symptoms of NAS in that time period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult female, opioid-dependent for at least 3 weeks prior to delivery.

          -  adult female, otherwise healthy.

          -  adult female, age 18-45 years inclusive.

          -  adult female, signed consent to participate for self and neonate (maternal subject may
             decide not to receive the study drug but her neonate can still be included in the
             study).

          -  neonate, gestational age 37 weeks through 41 weeks and 6 days at birth.

          -  neonate, corrected QT interval (QTc) from 12-lead electrocardiogram (ECG) less than
             480 milliseconds (ms).

        Exclusion Criteria:

          -  adult female, any condition that, in the opinion of the investigator, would compromise
             the health of the participant (both mother and fetus) or the integrity of the data.

          -  adult female, known allergy to study drug (ondansetron).

          -  adult female, screening 12-lead ECG, if done, showing prolonged QTc will stop the
             mother from receiving any study drug but her neonate can still be included in the
             study.

          -  adult female, not dependent on opioids for at least 3 weeks prior to delivery.

          -  adult female, generally not healthy.

          -  adult female, age 17 years or less or 46 years of age and older.

          -  adult female and neonate, the maternal ingestion or administration of ondansetron
             within 24 hours prior to delivery, for reasons other than study purposes, will exclude
             the mother and the neonate.

          -  neonate, preterm or post-term gestational age at delivery.

          -  neonate, QTc showing results greater than or equal to 480ms on any 12-lead ECG post
             delivery will stop the dosing of the study drug, but safety follow up will be done if
             the mother or baby received at least one dose of study drug.