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

Cognitive-, neurodevelopment and long-term health follow-up of children born after preterm prelabor rupture of membranes. - PPROMEXIL Follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47933
Enrollment
719
Registered
2019-04-16
Start date
2018-08-03
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

Lange termijn ontwikkeling Preterm prelabor rupture of membranes and long-term cognitive- en neurodevelopment

Interventions

Cognitive-
neurodevelopment
Preterm premature rupture of membranes

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Singletons born to women who participated in the PPROMEXIL or PPROMEXIL-II trial (PPROMEXIL trial registered as ISRCTN05689407, PPROMEXIL-II approved by the Medical Ethics Committee of the Maastricht University Medical Center as an amendment of the PPROMEXIL trial: MEC 05-240).

Exclusion criteria

Exclusion criteria: None. This is a follow-up study, all singletons included in the PPROMEXIL or PPROMEXIL-II trial can participate.

Design outcomes

Primary

MeasureTime frame
Primary Objective: Child*s cognitive development.

Secondary

MeasureTime frame
Secondary outcome: Child*s motor-, academic-, and behavioural development. Child*s general health (diseases, hospital admissions), child*s growth; as measured by length, weight, body composition, head circumference, blood pressure and child*s pulmonary function and respiratory problems.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)