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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Obstetric Labour, Premature

Treatments: Drug: Atosiban; Drug: Placebo; Drug: Retosiban

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292784

200722

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 10 to 20 weeks old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 3 patient groups, including a placebo group

Placebo (200719 study)

Placebo Comparator group

Description:

All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous \[IV\] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study will not require any medical interventions or study visits to an investigational site.

Treatment:

Drug: Placebo

Retosiban (200719 and 200721 study)

Experimental group

Description:

All infants and children born to women who received retosiban (6 milligram \[mg\] IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study will not require any medical interventions or study visits to an investigational site.

Treatment:

Drug: Retosiban

Atosiban (200721 study)

Active Comparator group

Description:

All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 mg using atosiban 6.75 mg per 0.9 milliliter \[mL\] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study will not require any medical interventions or study visits to an investigational site.

Treatment:

Drug: Atosiban