Completed

Study 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.

GSK Study ID:

200722


ClinicalTrials.gov Identifier:

NCT02292784


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Women's Health & Pregnancy - Other

Product

retosiban

Collaborators

PPD


Date

June 2015 to September 2019

Type

Interventional

Phase

3


Gender

All

Age

10 Weeks - 20 Weeks

Accepts Healthy Volunteers

No


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Belgium, Gent 9000Completed
Germany, Jena 07745Completed
Germany, Baden-Wuerttemberg, Freiburg 79106Completed
Israel, Hadera 38100Completed
Israel, Haifa 31048Completed
Israel, Holon 58100Completed
Israel, Kfar Saba 44281Completed
Israel, Petach Tikva 49100Completed
Israel, Safed 13100Completed
Israel, Tel-Aviv 64239Completed
Italy, Monza 20052Completed
Italy, Toscana, Siena 53100Completed
Japan, Miyagi 989-3126Completed
Japan, Miyazaki 889-1692Completed
Mexico, Jalisco, Guadalajara 44340Completed
Mexico, Nuevo León, Monterrey 64460Completed
Mexico, Sonora, Ciudad Obregon 85000Completed
South Korea, Seongnam 463-712Completed
South Korea, Seoul 135-081Completed
South Korea, Seoul 120-752Completed
Spain, Zaragoza 50009Completed
Sweden, UPPSALA SE-751 85Completed
United Kingdom, London SE1 7EHCompleted
United Kingdom, Tyne & Wear, Sunderland SR4 7TPCompleted
United States, Illinois, Park Ridge 60068Completed
United States, Texas, Galveston 77555-0587Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: Yes
  • Masked Investigator: Yes
  • Masked Assessor: Yes
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

Arms:
  • 4

Interventions:

  • Drug: Retosiban
  • Drug: Atosiban
  • Drug: Placebo

Keyword:

  • infants, retosiban, Preterm Labor, long-term safety follow-up
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 99