Trial · NCT03134703
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Stay (LOS) | 25 days | Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent. |
| Secondary | Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | inpatient and at 6-8 weeks of age | The Postpartum Bonding Questionnaire (PBQ) is a self-rating questionnaire designed to detect disorders of the mother-infant relationship. The questionnaire has 25 statements, each with six alternative responses ranging from 0 (always) to 5 (never). For the PBQ, scores are summated for each factor, with a high score indicating concern for bonding. The PBQ yields a total score between 0 to 125. Positive responses are scored from 0 ('always') to 5 ('never'). Negative responses, are scored from 5 ('always') to 0 ('never'). Factor 1 (impaired bonding) is based on 12 questions, with a score range 0-60 (0-11=normal; 12 \& above=high). Factor 2 (rejection \& anger) is based on 7 questions with a score range 0-35 (0-16=normal; 17 \& above=high). Factor 3 (anxiety about care) is based on 4 questions with a score range 0-20 (0-9=normal; 10 \& above =high). Factor 4 (risk of abuse) is based on 2 questions, with a score range 0-10 (0-2=normal; 3 \& above =high). |
| Secondary | Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS) | While inpatient and at 6-8 weeks of age | The Edinburgh Postnatal Depression Scale (EPDS) was developed for screening postpartum women in outpatient, home visiting settings, or at the 6-8 week postpartum examination. The EPDS is a 10-item questionnaire with responses scored 0, 1, 2, or 3 according to increased severity of the symptom. The maximum total score is 30 while the minimum score is 0. A score of 10 or greater, as well as any answer choice other than "never" on question #10 (suicidal thoughts) of the EPDS are indicative of depressive symptomatology. |
| Secondary | Readmission to Hospital | Within 30 days of discharge | Number of hospital readmissions |
| Secondary | Breast Milk | 30 days of age | Compare the incidence of providing breast milk (\> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants |
| Secondary | Infant Development | 4, 8 and 12 months of age | Assess the age appropriate infant development at 4, 8 and 12 months of age among the methadone treatment group using the Ages and Stages-based questionnaires (ASQ). The questionnaires are screening tools designed to identify infants at risk for developmental delays through caregivers' provision of quantitative information regarding their infant's development. In the ASQ, higher scores indicate more positive outcomes. The ASQ covers 5 areas of development: communication, gross motor, fine motor, problem solving, and personal-social. Scores for each area should fall between 0-60. Scoring: 0-30 = further assessment with a professional may be needed 30-40 = learning activities \& monitoring are indicated 45-60 = child development appears to be on schedule |
| Secondary | Screened vs. Eligible | After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial. | Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project |
| Secondary | Attrition Rate | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care |
| Secondary | Home Care | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial | Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge |
| Secondary | Readiness of Mothers to Assess Infant | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home |
| Secondary | Compliance With Pediatrician Visits | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03134703/registered