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

Induction 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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21277

Enrollment

728

Registered

2017-12-28

Start date

2017-12-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General health

Interventions

A 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 exp

Eligibility

Inclusion criteria

Inclusion criteria: All singletons (n=728) born after late PPROM in two previously performed RCTs (PPROMEXIL and PPROMEXIL-II).

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Cognitive development as measured by full IQ, verbal comprehension, perceptional organization, processing speed and, executive functioning	—

Secondary

Measure	Time frame
Neurologic 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.	—

Measure

Time frame

Neurologic 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.

—

Contacts

Public ContactN.E. Simons

AMC

followup.ppromexil@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)