Last updated: 09/27/2021 14:20:06
Follow up study to assess long term safety and outcomes in infants and children born to mothers participating in retosiban treatment studiesARIOS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of infants with newly diagnosed (after 28 days post estimated date of delivery) chronic medical conditions
Timeframe: Up to 24 months
Number of children with newly diagnosed (after 28 days post estimated date of delivery) chronic medical conditions
Timeframe: Up to 24 months
Number of infants with newly diagnosed congenital anomalies
Timeframe: Up to 24 months
Number of children with newly diagnosed congenital anomalies
Timeframe: Up to 24 months
Number of infant deaths
Timeframe: Up to 24 months
Number of child deaths
Timeframe: Up to 24 months
Number of infants with an Ages and Stages Questionnaire-3 [ASQ-3] score in the black zone for any domain
Timeframe: Up to 24 months
Number of infants with an ASQ-3 score in the black zone for gross motor skills
Timeframe: Up to 24 months
Number of infants with an ASQ-3 score in the black zone for fine motor skills
Timeframe: Up to 24 months
Number of infants with an ASQ-3 score in the black zone for communication
Timeframe: Up to 24 months
Number of infants with an ASQ-3 score in the black zone for problem solving
Timeframe: Up to 24 months
Number of infants with an ASQ-3 score in the black zone for personal-social skills
Timeframe: Up to 24 months
Number of infants referred for developmental evaluation (using Bayley Scales of Infant Development, third edition (BSID III)
Timeframe: Up to 24 months
Number of infants with a BSID-III score >2 SD below the mean score for the cognitive scale (<4)
Timeframe: Up to 24 months
Number of infants with a BSID-III score >2 SD below the mean score for the gross motor scale (<4)
Timeframe: Up to 24 months
Number of infants with a BSID-III score >2 SD below the mean score for the fine motor scale (<4)
Timeframe: Up to 24 months
Number of infants with a BSID-III score >2 SD below the mean score for the language scale (<70)
Timeframe: Up to 24 months
Number of infants with a Child Behavior Checklist (CBCL/1.5-5) score above the 97th percentile for a subset of prespecified questions that relate to attention and hyperactivity problems
Timeframe: Up to 24 months
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)
Timeframe: Up to 24 months
Number of infants referred for neurological evaluation to determine diagnosis of cerebral palsy
Timeframe: Up to 24 months
Number of infants with at least 1 of the indicators of neurodevelopmental impairment
Timeframe: Up to 24 months
Secondary outcomes:
Not applicable
Interventions:
Drug: Retosiban
Drug: Atosiban
Drug: Placebo
Enrollment:
98
Observational study model:
Not applicable
Primary completion date:
2019-02-09
Time perspective:
Not applicable
Clinical publications:
Marcy Powell, George Saade, Steve Thornton, Jeanne Pimenta, Nazneen Haque, Diane Miller, Kathleen Beach, Jerry Snidow, Erika Ochoa Correa, Rhona Scott. Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Trials: ARIOS Follow-up Study. Am J Perinatol. 2021;
DOI: 10.1055/s-0041-1733784
PMID: 34352924
Medical condition
Obstetric Labour, Premature
Product
retosiban
Collaborators
PPD
Study date(s)
June 2015 to September 2019
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
10 - 20 Weeks
Accepts healthy volunteers
No
- 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.
- There are no formal exclusion criteria for participation.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555-0587
Status
Study Complete
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
Location
GSK Investigational Site
Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-02-09
Actual study completion date
2019-02-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website