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Neolifes Heart - Pulmonary Hypertension in Preterm Children

NCT02729844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Bronchopulmonary Dysplasia

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Rolf Berger · University Medical Center Groningen

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2021-08-25
Completion
2021-08-25

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729844 on ClinicalTrials.gov