Clinical trial NCT02292784: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Official title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstetric Labour, Premature
Keywords: infants
retosiban
Preterm Labor
long-term safety follow-up
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2014-11-17
Enrollment: 98
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Infants and Children With Newly Diagnosed Chronic Medical Conditions (After 28 Days Post Estimated Date of Delivery)
timeFrame: From 28 days post estimated date of delivery up to 24 months
measure: Number of Infants and Children With Newly Diagnosed Congenital Anomalies (After 28 Days Post Estimated Date of Delivery)
timeFrame: From 28 days post estimated date of delivery up to 24 months
measure: Number of Infant and Child Death (After 28 Days Post Estimated Date of Delivery)
timeFrame: From 28 days post estimated date of delivery up to 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 9 Months
timeFrame: At 9 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 18 Months
timeFrame: At 18 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Any Domain at 24 Months
timeFrame: At 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Gross Motor Skills
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Fine Motor Skills
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Communication Skills
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Problem Solving Skills
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Ages and Stages Questionnaire-3 (ASQ-3) Score in the Black Zone for Personal Social Skills
timeFrame: 9, 18 and 24 months
measure: Number of Infants Referred for Developmental Evaluation Using Bayley Scales of Infant Development, Third Edition (BSID-III)
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Cognitive Scale (Less Than 4)
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Gross Motor Scale (Less Than 4)
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Fine Motor Scale (Less Than 4)
timeFrame: 9, 18 and 24 months
measure: Number of Infants With Bayley Scales of Infant Development, Third Edition Score Greater Than 2 Standard Deviation Below the Mean Score for the Language Scale (Less Than 70)
timeFrame: 9, 18 and 24 months
measure: Number of Infants With a Child Behavior Checklist for Ages 1.5 to 5 Years (CBCL/1.5 to 5) Score Above the 97th Percentile for a Subset of Prespecified Questions That Relate to Attention and Hyperactivity Problems
timeFrame: At 24 months
measure: 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: 18 and 24 months
measure: Number of Infants Referred for Neurological Evaluation to Determine Diagnosis of Cerebral Palsy
timeFrame: At 24 months
measure: Number of Infants With the Indicators of Neurodevelopmental Impairment
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: GSK Investigational Site
state: Illinois
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Jena
country: Germany
facility: GSK Investigational Site
city: Hadera
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Safed
country: Israel
facility: GSK Investigational Site
city: Tel-Aviv
country: Israel
facility: GSK Investigational Site
city: Siena
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Monza
country: Italy
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Miyazaki
country: Japan
facility: GSK Investigational Site
city: Seongnam
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Ciudad Obregon
country: Mexico
facility: GSK Investigational Site
state: Sonora
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Sunderland
country: United Kingdom
facility: GSK Investigational Site
state: Tyne & Wear
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: