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

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ClinicalTrials.gov Identifier: NCT02292784
Recruitment Status : Active, not recruiting
First Posted : November 17, 2014
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline

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 planned 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 5 years 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.

Condition or disease Intervention/treatment Phase
Obstetric Labour, Premature Drug: Retosiban Drug: Atosiban Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : July 29, 2022
Estimated Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
All infants and children exposed to placebo during their mother's participation in a Phase III SPTL treatment study for SPTL
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

Experimental: Retosiban
All infants and children born to women who received at least 1 dose of retosiban in SPTL treatment study treatment group
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.

Active Comparator: Atosiban
All infants and children born to women who received at least 1 dose of atosiban in SPTL treatment study treatment group
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.

Active Comparator: All comparator
This group will include the pooling of placebo and atosiban into a group called all comparators
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




Primary Outcome Measures :
  1. Number of infants and children with newly diagnosed (after 28 days post estimated date of delivery) chronic medical conditions [ Time Frame: Up to 5 years ]
    Chronic medical conditions will include: respiratory (chronic lung disease, reactive airway disease, vocal cord paralysis, airway obstruction), neurological (cerebral palsy, seizure disorder, hydrocephalus requiring shunt), sensory (vision [vision impairment, blindness in 1 or both eyes], hearing [hearing impairment, deafness in 1 or both ears, hearing impaired defined as uncorrected even with aids]), gastrointestinal (gastroesophageal reflux disease, tube/parenteral feeding, short bowel syndrome), cardiovascular (pulmonary hypertension, hypertension), renal (renal impairment requiring dialysis), growth parameters (poor weight gain, reduced length, reduced head circumference, failure to thrive)

  2. Number of infants and children with newly diagnosed congenital anomalies [ Time Frame: Up to 5 years ]
    A congenital anomaly is a condition present at birth that results from malformation, deformation, or disruption in 1 or more parts of the body, a chromosomal abnormality, or a known clinical syndrome.

  3. Number of infant and child deaths [ Time Frame: Up to 5 years ]
    Number of infant and child deaths that occur after 28 days post estimated date of delivery (EDD) and until the end of the study (up to 5 years chronological age) will be assessed

  4. Proportion of infants with an Ages and Stages Questionnaire-3[ASQ-3] score in the black zone for any domain, for gross motor skills, for fine motor skills, for communication, for problem solving and for personal-social skills [ Time Frame: At 9, 18 and 24 months, corrected for prematurity, up to 24 months ]
    The parent/legal guardian will be asked to complete standardized developmental screening of the infant through completion of the ASQ-3. The ASQ-3 includes a series of questions designed to assess 5 areas of development: communication, gross motor, fine motor, problem solving, and personal social. The questions target behaviours that are appropriate for particular developmental milestones.

  5. Proportion of infants referred for developmental evaluation (using Bayley Scales of Infant Development, third edition (BSID III) [ Time Frame: Up to 27 months ]
    If any of the child's ASQ-3 scores are in the black zone (>/=2 SD below the mean), the child's parent/legal guardian will be asked if the child is already under the care of a developmental specialist who can or has made a formal assessment (e.g., using the BSID-III). If the child is not currently under the care of a developmental specialist, then the parent/legal guardian will be referred to a qualified assessor for developmental evaluation using the BSID-III.

  6. Proportion of infants with a BSID-III score >2 SD below the mean score for the cognitive scale (<70), for the gross motor scale (<70), for the fine motor scale (<70) and for the language scale (<70) [ Time Frame: Up to 27 months ]
    BSID-III is a tool used for developmental evaluation of the child.

  7. Proportion of infants with a Child Behavior Checklist (CBCL/1.5-5) score at or above the 97th percentile for a subset of prespecified questions that relate to attention and hyperactivity problems [ Time Frame: Up to 27 months ]
    The CBCL/1.5-5 questionnaire is a parent-completed questionnaire used for assessing behavioral problems and social competencies. It includes approximately 100 items that describe specific kinds of behavioral, emotional, and social problems that characterize preschool children between the ages of 1.5 and 5 years. Scores above the 97th percentile are in the significant range of clinical concern.

  8. Proportion 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) [ Time Frame: Up to 27 months ]
    The M-CHAT-R/F is a parent-reported autism screening tool designed to identify children 16 to 30 months of age who should receive a more thorough assessment for possible early signs of autism spectrum disorder (ASD) or developmental delay

  9. Proportion of infants referred for neurological evaluation to determine diagnosis of cerebral palsy [ Time Frame: Up to 27 months ]
    Cerebral palsy, defined as a chronic, nonprogressive neurologic disorder encompassing impaired motor function affecting movement, posture, balance muscle control, coordination, tone, or reflexes

  10. Proportion of infants with at least 1 of the indicators of neurodevelopmental impairment [ Time Frame: Up to 27 months ]
    The indicators of neurodevelopmental impairment are: 1) Hearing impaired, uncorrected even with aids 2) Blindness in 1 or both eyes, or sees light only, 3) Cerebral palsy (moderate and severe), 4) Cognitive impairment: BSID-III Cognitive Scale Score of <2 SDs below mean score (<70), 5) Motor impairment: BSID-III Motor Composite Scale Score of <2 SDs below mean score (<70)

  11. Parental productivity loss related to a sick child and infant resource utilization in terms of number of hospital admissions [ Time Frame: Up to 27 months ]
    Number of hospital admissions, proportion of infants with any hospital admission, post-birth hospitalization discharge, by principal and secondary discharge diagnosis, type of hospital unit admitted to (example neonatal intensive care unit [NICU], Pediatric, pediatric intensive care unit [PICU], Nursery level 3, intensive care unit [ICU]), and length of hospital stay per unit after 28 days post EDD

  12. Parental productivity loss related to a sick child and infant resource utilization in terms of combined length of hospital stay for all hospital admissions [ Time Frame: Up to 27 months ]
    Combined length of hospital stay in days for all hospital admissions (for infants discharged from the delivery hospitalization and for babies who were never discharged home post-delivery) after 28 days post EDD

  13. Parental productivity loss related to a sick child and infant resource utilization in terms of number of emergency room/urgent care (ER/UC) visits and number of subjects with any ER/UC visit after 28 days post EDD [ Time Frame: Up to 27 months ]
    Number of emergency room/urgent care (ER/UC) visits and number of subjects with any ER/UC visit after 28 days post EDD

  14. Parental productivity loss related to a sick child and infant resource utilization in terms of number of surgical procedures [ Time Frame: Up to 27 months ]
    This outcome will be assessed by the type of procedure and whether performed on an inpatient basis or at an outpatient/surgical center) after 28 days post EDD

  15. Parental productivity loss related to a sick child and infant resource utilization in terms of number of speciality care or therapy visits and number of subjects referred for speciality care or therapy [ Time Frame: Up to 27 months ]
    This outcome will be assessed by the type of speciality care or therapy after 28 days post EDD

  16. Proportion of infants and children with at least 1 of the indicators of neurodevelopmental impairment at the end of the study [ Time Frame: Up to 5 years ]
    The indicators of neurodevelopmental impairment are: 1) Hearing impaired, uncorrected even with aids 2) Blindness in 1 or both eyes, or sees light only 3) Cerebral palsy (moderate and severe 4) Diagnosis of ASD, ADD or ADHD



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Weeks to 20 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 participants 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292784


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Sponsors and Collaborators
GlaxoSmithKline
PPD
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02292784     History of Changes
Other Study ID Numbers: 200722
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
infants
retosiban
Preterm Labor
long-term safety follow-up

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Atosiban
Vasotocin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents
Oxytocics
Vasoconstrictor Agents