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

Recruiting

• Conditions: General health; cognitive development; IQ; neuromotoric outcome; cerebral palsy; behaviour; general health; respiratory problems; anthropometrics

• Registration Number: NL-OMON21277
• Lead Sponsor: Academical Medical Center (AMC), Amsterdam, The Netherlands

Brief Summary

one

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 728

Inclusion Criteria

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

Exclusion Criteria

N/A

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive development as measured by full IQ, verbal comprehension, perceptional organization, processing speed and, executive functioning

Secondary Outcome Measures

Name	Time	Method
eurologic 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<br>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<br>practitioners.