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van CCT (UK)

van CCT (UK)

Cognitive-, neurodevelopment and long-term health follow-up of children born after preterm birth and preterm premature rupture of membranes.

- candidate number28386
- NTR NumberNTR6953
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2017
- Secondary IDs843002826 - Projectnummer ZonMw ISRCTN05689407 (PPROMEXIL trial) + MEC 05-240 (PPROMEXIL-II trial)
- Public TitleCognitive-, neurodevelopment and long-term health follow-up of children born after preterm birth and preterm premature rupture of membranes.
- Scientific TitleInduction of labour or expectant management in women with PPROM between 34-37 weeks of gestation – a long-term follow-up and economic evaluation study of the PPROMEXIL-trial.
- hypothesisIn pregnancies complicated by late PPROM immediate delivery might lead to better long-term outcome.
- Healt Condition(s) or Problem(s) studiedCognitive development, IQ, Cerebral palsy, Behaviour, Respiratory problems
- Inclusion criteriaAll singletons (n=728) born after late PPROM in two previously performed RCTs (PPROMEXIL and PPROMEXIL-II).
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 31-dec-2017
- planned closingdate31-dec-2020
- Target number of participants728
- InterventionsA comprehensive long-term follow-up assessment and economic evaluation study of two multicenter randomized controlled trials (PPROMEXIL and PPROMEXIL-II trial) comparing induction of labour versus expectant management in women with PPROM between 34+0 and 36+6 weeks gestation. All children born to participants in the PPROMEXIL trials will be assessed on the long-term effects of these treatment regimens in a similar way at 8-11 years of corrected age. During a single hospital visit children will be assessed on cognitive, motor, neurological and behavioral development, respiratory problems and general health
- Primary outcomeCognitive development as measured by full IQ, verbal comprehension, perceptional organization, processing speed and, executive functioning
- Secondary outcomeNeurologic and motor outcome defined as gross and fine motor skills and the presence of Developmental Coordination Disorder (DCD), CP and severity of CP; Child’s ability of processing of sensory information; Behavioral development defined as internalizing and externalizing behavior, anxious/depressed behavior, sleeping problems, somatic problems, aggressive behavior, destructive behavior; Health-care related outcomes; such as need for healthcare providers, hospital visits and medication; Respiratory problems; Anthropometrics, such as height, weight, waist-hip ratio, head circumference, blood pressure; Cost-effectiveness per treatment-group measured by medical costs as well as non-medical community level costs, including costs associated with special educational services, costs for therapies or visits to health care services, visits to private practitioners.
- TimepointsWe will need a run-in period of 3 months for the study set up, and 30 months for inclusion. After inclusion of the last patient, 9 months will be needed for data collection and report of results. The first report on the results is expected at 3 years after the start of the study.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNone
- Brief summaryLate preterm premature rupture of membranes (PPROM) between 34-37 weeks’ gestation increases the risk of infection. This could be an indication to induce delivery, inevitably leading to prematurity. Alternatively an expectant management till 37 weeks could be contemplated. Two large recent RCTs(PROMEXIL and PPROMEXIL-II ) evaluated both treatments and concluded that based on the short term outcome expectant management should be favored. However, long-term outcomes of women's offspring have never been investigated. Therefore, we will assess survival, general health, cognitive, motor, neurologic and behavioural development and investigate children’s need for health-care services at 8-11 years of age. This study provides the unique opportunity to finally resolve the long debated question on the best treatment regimen in late PPROM.
- Main changes (audit trail)
- RECORD28-dec-2017 - 26-jan-2018

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