Phase 3
Completed N=98
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Obstetric Labour, Premature
Source: ClinicalTrials.gov NCT02292784 ↗
Enrolled (actual)
98
Serious AEs
9.2%
Results posted
Jul 2020
Primary outcomePrimary: Number of Infants and Children With Newly Diagnosed Chronic Medical Conditions (After 28 Days Post Estimated Date of Delivery) — 0; 1; 3 Participants
◆ Published Evidence
Emerging
1citation · ~0 / year
Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Trials: ARIOS Follow-up Study.
Summary
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.
Linked Publications
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Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Trials: ARIOS Follow-up Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants and Children With Newly Diagnosed Chronic Medical Conditions (After 28 Days Post Estimated Date of Delivery) |
0; 1; 3 | — |
| PRIMARY Number of Infants and Children With Newly Diagnosed Congenital Anomalies (After 28 Days Post Estimated Date of Delivery) |
0; 0; 2; 0; 0; 0 | — |
| PRIMARY Number of Infant and Child Death (After 28 Days Post Estimated Date of Delivery) |
0; 0; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 9 Months |
0; 4; 4 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 18 Months |
2; 5; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 24 Months |
1; 2; 2 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Gross Motor Skills |
0; 1; 0; 1; 1; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Fine Motor Skills |
0; 0; 2; 1; 2; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Communication Skills |
0; 1; 1; 1; 0; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Problem Solving Skills |
0; 1; 2; 0; 1; 0 | — |
| PRIMARY Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Personal Social Skills |
0; 2; 0; 0; 1; 0 | — |
| PRIMARY Number of Infants Referred for Developmental Evaluation Using Bayley Scales of Infant Development, Third Edition (BSID-III) |
1; 3; 2; 3; 0; 2 | — |
| PRIMARY Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Cognitive Scale (Less Than 4) |
0; 2; 1 | — |
| PRIMARY Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Gross Motor Scale (Less Than 4) |
0; 2; 1 | — |
| PRIMARY Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Fine Motor Scale (Less Than 4) |
0; 2; 1 | — |
| PRIMARY Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Language Scale (Less Than 70) |
0; 2; 1 | — |
| PRIMARY Number of Infants With a Child Behavior Checklist for Ages 1.5 to 5 Years (CBCL/1.5 to 5) Score Above the 97th Percentile for a Subset of Prespecified Questions That Relate to Attention and Hyperactivity Problems |
0; 1; 0 | — |
| PRIMARY Number of Infants Indicated as Needing Further Evaluation After Completion of the Modified Checklist for Autism in Toddlers- Revised With Follow-up (M-CHAT-R/F) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Infants Referred for Neurological Evaluation to Determine Diagnosis of Cerebral Palsy |
0; 0; 0 | — |
| PRIMARY Number of Infants With the Indicators of Neurodevelopmental Impairment |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
- Infant is alive at 28 days post EDD.
- Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
Exclusion Criteria
- There are no formal exclusion criteria for participation.
Data sourced from ClinicalTrials.gov (NCT02292784) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.