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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 : Completed
First Posted : November 17, 2014
Last Update Posted : September 25, 2019
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 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
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 2, 2019

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 with newly diagnosed (after 28 days post estimated date of delivery) chronic medical conditions [ Time Frame: Up to 24 months ]
    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 children with newly diagnosed (after 28 days post estimated date of delivery) chronic medical conditions [ Time Frame: Up to 24 months ]
    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)

  3. Number of infants with newly diagnosed congenital anomalies [ Time Frame: Up to 24 months ]
    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.

  4. Number of children with newly diagnosed congenital anomalies [ Time Frame: Up to 24 months ]
    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.

  5. Number of infant deaths [ Time Frame: Up to 24 months ]
    Number of infant deaths that occur after 28 days post EDD and until 24 months chronological age will be assessed

  6. Number of child deaths [ Time Frame: Up to 24 months ]
    Number of child deaths that occur after 28 days post EDD and until 24 months chronological age will be assessed

  7. Number of infants with an Ages and Stages Questionnaire-3 [ASQ-3] score in the black zone for any domain [ Time Frame: 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.

  8. Number of infants with an ASQ-3 score in the black zone for gross motor skills [ Time Frame: 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.

  9. Number of infants with an ASQ-3 score in the black zone for fine motor skills [ Time Frame: 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.

  10. Number of infants with an ASQ-3 score in the black zone for communication [ Time Frame: 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.

  11. Number of infants with an ASQ-3 score in the black zone for problem solving [ Time Frame: 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.

  12. Number of infants with an ASQ-3 score in the black zone for personal-social skills [ Time Frame: 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.

  13. Number of infants referred for developmental evaluation (using Bayley Scales of Infant Development, third edition (BSID III) [ Time Frame: Up to 24 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.

  14. Number of infants with a BSID-III score >2 SD below the mean score for the cognitive scale (<4) [ Time Frame: Up to 24 months ]
    BSID-III is a tool used for developmental evaluation of the child.

  15. Number of infants with a BSID-III score >2 SD below the mean score for the gross motor scale (<4) [ Time Frame: Up to 24 months ]
    BSID-III is a tool used for developmental evaluation of the child.

  16. Number of infants with a BSID-III score >2 SD below the mean score for the fine motor scale (<4) [ Time Frame: Up to 24 months ]
    BSID-III is a tool used for developmental evaluation of the child.

  17. Number of infants with a BSID-III score >2 SD below the mean score for the language scale (<70) [ Time Frame: Up to 24 months ]
    BSID-III is a tool used for developmental evaluation of the child.

  18. 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 [ Time Frame: Up to 24 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.

  19. 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) [ Time Frame: Up to 24 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

  20. Number of infants referred for neurological evaluation to determine diagnosis of cerebral palsy [ Time Frame: Up to 24 months ]
    Cerebral palsy, defined as a chronic, nonprogressive neurologic disorder encompassing impaired motor function affecting movement, posture, balance muscle control, coordination, tone, or reflexes

  21. Number of infants with at least 1 of the indicators of neurodevelopmental impairment [ Time Frame: Up to 24 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 (<4); 5) Motor impairment: BSID-III Motor Composite Scale Score of >2 SDs below mean score (<70); 6) Diagnosis of ASD, attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD).



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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 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.

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


Locations
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United States, Illinois
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Texas
GSK Investigational Site
Galveston, Texas, United States, 77555-0587
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Jena, Germany, 07745
Israel
GSK Investigational Site
Hadera, Israel, 38100
GSK Investigational Site
Haifa, Israel, 31048
GSK Investigational Site
Holon, Israel, 58100
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Petach Tikva, Israel, 49100
GSK Investigational Site
Safed, Israel, 13100
GSK Investigational Site
Tel-Aviv, Israel, 64239
Italy
GSK Investigational Site
Siena, Toscana, Italy, 53100
GSK Investigational Site
Monza, Italy, 20052
Japan
GSK Investigational Site
Miyagi, Japan, 989-3126
GSK Investigational Site
Miyazaki, Japan, 889-1692
Korea, Republic of
GSK Investigational Site
Seongnam, Korea, Republic of, 463-712
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 135-081
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
GSK Investigational Site
Ciudad Obregon, Sonora, Mexico, 85000
Spain
GSK Investigational Site
Zaragoza, Spain, 50009
Sweden
GSK Investigational Site
Uppsala, Sweden, SE-751 85
United Kingdom
GSK Investigational Site
Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
GSK Investigational Site
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
GlaxoSmithKline
PPD
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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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: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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