NCT02292784

Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Weeks – 20 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Obstetric Labour, Premature

Interventions

Type	Name	Description
DRUG	Retosiban	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.
DRUG	Atosiban	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.
DRUG	Placebo	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

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-09-02
• Completion: 2019-09-02
• First posted: 2014-11-17
• Last updated: 2020-07-09
• Results posted: 2020-07-09

Locations

26 sites across 11 countries: United States, Belgium, Germany, Israel, Italy, Japan, Mexico, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study