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

GSK study ID
200722
See study documents
Clinicaltrials.gov ID
NCT02292784
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2019-02-09
    Observational study model:
    Not applicable
    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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Ciudad Obregon, Sonora, Mexico, 85000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Freiburg, Baden-Wuerttemberg, Germany, 79106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0587
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guadalajara, Jalisco, Mexico, 44340
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hadera, Israel, 38100
    Status
    Study Complete
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    Showing 1 - 6 of 26 Results

    Study documents

    Clinical study report
    Available language(s): English
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    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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
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