CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02729844
NCT02729844N/ACompleted

Pulmonary Hypertension in Preterm Children Born at Gestational Age <30 Weeks: Prevalence, Risk Factors and Outcome

University Medical Center Groningen·observational·Posted Apr 6, 2016·Updated Dec 1, 2021

In Brief

An observational study for Pulmonary Hypertension and Bronchopulmonary Dysplasia. Completed, enrolled 134 participants across 1 site.

Detailed Summary

NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children. NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the vasculature of the lungs is often not fully developed, making them more vulnerable for the development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of the infants with extremely low birth weight are believed to develop PH, this proportion has been suggested to raise to 50% in infants with severe BPD. The presence of PH significantly worsens the prognosis and survival of these children. The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk factors for the development of PH and survival, will be the first step in improving detection strategies, possible treatment options and thereby prognosis and survival of these children. Objective: To determine the incidence and prevalence of PH in preterm infants. In addition we aim to identify risk factors for the development of PH and determine the survival and prognosis of these preterm infants. Study design: A prospective cohort study. Study population: All preterm infants, admitted at the neonatology UMCG, born \<30 weeks and/or birth weight \< 1000 gram, who participate in NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence). Secondary parameters: * Maternal and neonatal patient characteristics that are potential risk factors for the development of PH, * Morbidity-score (quality of life and hospital admissions) and mortality.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 6, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 25, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.2 years ago