Trial · NCT03396588
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
NCT03396588, Phase 3, Completed, Henrietta Bada; results first posted 2025-05-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain. Trials, record NCT03396588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03396588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
- NCT number
- NCT03396588
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- Henrietta Bada
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Clonidine, Morphine
- First posted
- 2018-01-11
- Last updated
- 2025-05-23
- Results first posted
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Baseline (5-10 days post natal age) and one-month post-natal age (between 4-6 weeks of age), or at discharge, whichever comes first. | The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29-8.4), Handling (0-1), quality of movement (1.20-6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43-6.67), hypertonicity (0-8), hypotonicity (0-5.0), excitability (0-11), lethargy (0-11.0), and stress/abstinence (0-0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. |
| Primary | Bayley Scales of Infant and Toddler Development Third Edition | 6 months of life | Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive, and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15 with a range of 55-155 for cognitive and a range of 45-155 for language and motor (lower scores indicating greater impairment). Scores below 1 standard deviation (=or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain. The score for each domain (motor, cognitive, and language functioning) represents the composite score. |
| Primary | Bayley Scales of Infant and Toddler Development Third Edition | 1 year of life | Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive, and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15 with a range of 55-155 for cognitive and a range of 45-155 for language and motor (lower scores indicating greater impairment). Scores below 1 standard deviation (=or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain. The score for each domain (motor, cognitive, and language functioning) represents the composite score. |
| Primary | Bayley Scales of Infant and Toddler Development Third Edition | 2 years of life | Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive, and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15 with a range of 55-155 for cognitive and a range of 45-155 for language and motor (lower scores indicating greater impairment). Scores below 1 standard deviation (=or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain. The score for each domain (motor, cognitive, and language functioning) represents the composite score. |
| Primary | Ages and Stages Questionnaire Third Edition (ASQ-3) | 12 months of age | The ASQ-3 is a developmental screening tool to assess developmental progress in children. Children are scored in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal/social skills. The child's parent/guardian answers whether their child already does an activity (yes=10), sometimes does it (sometimes=5), or does not yet do it (not yet=0). The answers are then used to score each category. Each category is then broken down into whether the child falls above the cutoff (child development is on schedule), close to the cutoff (child development is slightly delayed and requires monitoring/intervention), or below the cutoff (delayed development and further assessment required). |
| Primary | Ages and Stages Questionnaire Third Edition (ASQ-3) | 24 months | The ASQ-3 is a developmental screening tool to assess developmental progress in children. Children are scored in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal/social skills. The child's parent/guardian answers whether their child already does an activity (yes=10), sometimes does it (sometimes=5), or does not yet do it (not yet=0). The answers are then used to score each category. Each category is then broken down into whether the child falls above the cutoff (child development is on schedule), close to the cutoff (child development is slightly delayed and requires monitoring/intervention), or below the cutoff (delayed development and further assessment required). |
| Primary | Childhood Behavior Checklist (CBCL) T-Scores | Once post discharge (between 18 months up to 24 months of age) | The CBCL/1.5-5 is validated for children ages 1.5 to 5 years old. It obtains caregivers' ratings of 113 behavior items. Scores are broken down into internalizing problems (scores range 29-100, normal is below 60), externalizing problems (scores range from 28-100, normal is below 60), and total problems (range is 28-100, normal is below 60). Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. Items are also scored on the following DSM-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. The CBCL consists of 113 items, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often) |
| Secondary | Duration of Treatment | 60 days | Total number days of treatment |
| Secondary | Childhood Behavior Checklist 1.5-5 T-Scores | Once post discharge (between 18 months up to 24 months of age) | On the CBCL 1.5-5, T-scores, with a mean of 50 and a standard deviation of 10, are used to interpret results, with scores of 65 or higher indicating a clinical range, and scores between 60 and 64 suggesting a borderline clinical range. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Baseline (5-10 days post natal age) and one-month post-natal age (between 4-6 weeks of age), or at discharge, whichever comes first. | Some babies were unable to be assessed in certain domains and therefore were not included in the total analyzed for that domain. | score on a scale | MEAN |
| PRIMARY | Bayley Scales of Infant and Toddler Development Third Edition | 6 months of life | Participants may not have had the 6 month Bayley due to the participant being lost to follow up, or because of COVID-19 research restrictions. | score on a scale | MEAN |
| PRIMARY | Bayley Scales of Infant and Toddler Development Third Edition | 1 year of life | Participants may not have had the 12 month Bayley due to the participant being lost to follow up, or because of COVID-19 research restrictions. | score on a scale | MEAN |
| PRIMARY | Bayley Scales of Infant and Toddler Development Third Edition | 2 years of life | Participants may not have had the 24 month Bayley due to the participant being lost to follow up, or because of COVID-19 research restrictions. | score on a scale | MEAN |
| PRIMARY | Ages and Stages Questionnaire Third Edition (ASQ-3) | 12 months of age | ASQ-3 assessments were used for babies who were unable to have Bayley assessment performed due to COVID-19 research restrictions. The babies who had the Bayley did not have the ASQ. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Ages and Stages Questionnaire Third Edition (ASQ-3) | 24 months | The ASQ-3 at 24 months was used for babies who were unable to have the Bayley assessment due to COVID-19 research restrictions.~The babies who had the Bayley did not have the ASQ performed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Childhood Behavior Checklist (CBCL) T-Scores | Once post discharge (between 18 months up to 24 months of age) | Only children in the treated cohorts had the CBCL.~Participants who were considered lost to follow up did not have the CBCL. | score on a scale | MEAN |
| SECONDARY | Duration of Treatment | 60 days | days | MEAN | |
| SECONDARY | Childhood Behavior Checklist 1.5-5 T-Scores | Once post discharge (between 18 months up to 24 months of age) | Participants who were lost to follow up did not have the CBCL. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Clonidine | Habituation | 0.5 | 95% Confidence Interval -1.0 to 1.0 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Morphine | Habituation | 0.3 | 95% Confidence Interval -1.0 to 1.0 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Clonidine | Attention | 1.0 | 95% Confidence Interval -0.1 to 2.0 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Morphine | Attention | 0.6 | 95% Confidence Interval 0.2 to 1.6 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Clonidine | Handling | -0.1 | 95% Confidence Interval -0.4 to 0.1 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Morphine | Handling | 0.1 | 95% Confidence Interval 0.0 to 0.4 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Clonidine | Quality of movement | 0.1 | 95% Confidence Interval -0.3 to 0.8 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Morphine | Quality of movement | 0.0 | 95% Confidence Interval -0.5 to 0.5 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Clonidine | Regulation | 0.5 | 95% Confidence Interval -0.5 to 1.3 | score on a scale |
| Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) | Morphine | Regulation | -0.2 | 95% Confidence Interval -0.8 to 0.2 | score on a scale |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clonidine | 60 | |
| Overall Study | STARTED | Morphine | 60 | |
| Overall Study | COMPLETED | Clonidine | 58 | |
| Overall Study | COMPLETED | Morphine | 57 | |
| Overall Study | NOT COMPLETED | Clonidine | 2 | |
| Overall Study | NOT COMPLETED | Morphine | 3 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Finnegan scores consecutively >8 | Nervous system disorders | Clonidine | 24 | 60 | |
| other | Finnegan scores consecutively >8 | Nervous system disorders | Morphine | 17 | 60 | |
| other | Adjunct medication added | Investigations | Clonidine | 13 | 60 | |
| other | Adjunct medication added | Investigations | Morphine | 2 | 60 | |
| other | Phenobarbitol added | Investigations | Clonidine | 15 | 60 | |
| other | Phenobarbitol added | Investigations | Morphine | 5 | 60 | |
| serious | Sustained tachycardia | Cardiac disorders | Clonidine | 3 | 60 | |
| serious | Sustained tachycardia | Cardiac disorders | Morphine | 4 | 60 | |
| serious | Skin lesions | Skin and subcutaneous tissue disorders | Clonidine | 2 | 60 | |
| serious | Skin lesions | Skin and subcutaneous tissue disorders | Morphine | 1 | 60 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clonidine | 1 | 60 |
| Total, all-cause mortality | Morphine | 0 | 60 |
| Total, other adverse events | Clonidine | 52 | 60 |
| Total, other adverse events | Morphine | 24 | 60 |
| Total, serious adverse events | Clonidine | 9 | 60 |
| Total, serious adverse events | Morphine | 15 | 60 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA043519 | Non-opiate treatment after prenatal opiate exposure to Prevent Postnatal Injury to the Young Brain (No-POPPY) | BADA, HENRIETTA S.; LEGGAS, MARKOS | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DRUG ABUSE | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clonidine vs Morphine: deaths from any cause | Trial comparisons |
| Clonidine vs Morphine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03396588
GET https://conductscience.org/api/trials/v1/NCT03396588/results?page=2