Amnioninfusion or expected management after midtrimester PPROM * what are the long-term effects on offspring*s general health and neurobehavioral development?

Amnioninfusion or expected management after midtrimester PPROM * what are the long-term effects on offspring*s general health and neurobehavioral development? - Follow-up of the PPROMXIL-III trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45320

Enrollment

Registered

2018-01-09

Start date

2018-01-20

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

Cognitieve, neuromotorische en longfunctie ontwikkeling Preterm premature rupture of membranes and long-term development

Interventions

Amnioninfusion

Cognitive- and neurological development

Long-term follow-up

Midtrimester preterm premature rupture of membranes

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Women who participated in the PPROMEXIL-III trial and their offspring (singletons born in the PPROMEXIL-III trial). The PPROMEXIL-III trial has been registrated as: NL36645.081.11, NTR 3492.

Exclusion criteria

Exclusion criteria: None. This is a follow-up study, all women and their offspring who participated in the PPROMEXIL-III trial can participate.

Design outcomes

Primary

Measure	Time frame
Child*s neurological development	—

Secondary

Measure	Time frame
At age 2-3 years: - Childs cognitive development - Childs languages development - Childs behavior and social-emotional development - Childs attention difficulties - Childs general health and psychological problems (diseases, hospital admissions) - Childs growth (height, weight, head circumference) - Child*s pulmonary function and respiratory problems - Quality of life of women who participated in the PPROMEXIL-III trial	—

Measure

Time frame

At age 2-3 years: - Child*s cognitive development - Child*s languages development - Child*s behavior and social-emotional development - Child*s attention difficulties - Child*s general health and psychological problems (diseases, hospital admissions) - Child*s growth (height, weight, head circumference) - Child*s pulmonary function and respiratory problems - Quality of life of women who participated in the PPROMEXIL-III trial

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)