Neolifes Heart - Pulmonary Hypertension in Preterm Children
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|ClinicalTrials.gov Identifier: NCT02729844|
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : October 17, 2019
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).
- 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.
|Condition or disease|
|Pulmonary Hypertension Bronchopulmonary Dysplasia|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||165 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Pulmonary Hypertension in Preterm Children Born at Gestational Age <30 Weeks: Prevalence, Risk Factors and Outcome|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
All premature infants, admitted at the neonatal intensive care unit (NICU) of the University Medical Centre Groningen, born <30 weeks or birth weight < 1000 gram, who participate in NeolifeS
- Incidence of pulmonary hypertension [ Time Frame: at 12 months corrected age. ]
- Mortality [ Time Frame: At 12 months corrected age. ]survival
- Morbidity [ Time Frame: at 12 months corrected age ]Quality of life questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729844
|Contact: Sanne Arjaansfirstname.lastname@example.org|
|Contact: Rolf Bergeremail@example.com|
|University Medical Centre Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: Sanne Arjaans +3150-3612800 firstname.lastname@example.org|
|Principal Investigator:||Rolf Berger||University Medical Center Groningen|