Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT03134703
Eligibility Criteria:
Methadone Treatment Group:
Inclusion criteria:
1. Baby is diagnosed with neonatal abstinence syndrome;
2. Mother under the care of Operation PAR;
3. Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
4. Mother has been deemed by PAR officials as being compliant with the detoxification program;
5. Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
6. Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
7. No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
8. Newborns ≥ 37 0/7 weeks gestation;
9. Newborns transferred to JHACH within 72 hours from birth;
10. Newborns ≥ 2.5 kg weight at birth;
11. Informed parental consent.
Exclusion Criteria:
1. Major congenital anomalies;
2. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
3. Infants who are being placed for adoption;
4. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
5. Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
6. Mother with hearing or language impairment
Comparison Group:
Inclusion Criteria:
1. Baby is diagnosed with neonatal abstinence syndrome;
2. Newborns ≥ 37 0/7 weeks gestation;
3. Newborns transferred to JHACH within 72 hours from birth;
4. Newborns ≥ 2.5 kg weight at birth;
5. Informed parental consent.
Exclusion Criteria:
1. Infant not requiring pharmacologic treatment for NAS;
2. Major congenital anomalies;
3. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
4. Infants who are being placed for adoption;
5. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
6. Mother with hearing or language impairment;
7. Infants known upon admission who will be placed into state custody or sheltered.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
72 Hours
Study:
NCT03134703
Study Brief:
Protocol Section:
NCT03134703