Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Intervention: Retosiban; Atosiban; Placebo
Intervention description: This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.; This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.; This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
Intervention MeSH terms: Atosiban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 10 Weeks
Maximum age: 20 Weeks
Healthy volunteers: No
Keywords: infants; retosiban; Preterm Labor; long-term safety follow-up

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.
    

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.