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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 : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. dr. R.M.F. Berger, University Medical Center Groningen

Brief 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.

Condition or disease
Pulmonary Hypertension Bronchopulmonary Dysplasia

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Neolifes Heart
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



Primary Outcome Measures :
  1. Incidence of pulmonary hypertension [ Time Frame: at 12 months corrected age. ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: At 12 months corrected age. ]
    survival

  2. Morbidity [ Time Frame: at 12 months corrected age ]
    Quality of life questionnaire



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All premature infants, admitted at the neonatology UMCG, born <30 weeks or birth weight < 1000 gram, who participate in NeolifeS
Criteria

Inclusion Criteria:

  • All premature infants born <30 weeks or <100 gram
  • admitted at the neonatology UMCG,
  • participation in the study Neolifes

Exclusion Criteria:

  • no informed consent

Information from the National Library of Medicine

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


Contacts
Contact: Sanne Arjaans +31641882427 s.arjaans@umcg.nl
Contact: Rolf Berger +3150-3612800 r.m.f.berger@umcg.nl

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Sanne Arjaans    +3150-3612800    s.arjaans@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Rolf Berger University Medical Center Groningen

Publications:

Responsible Party: Prof. dr. R.M.F. Berger, Prof. Dr. R.M.F. Berger, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02729844     History of Changes
Other Study ID Numbers: 201500715
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only in case of clinical need, the data of the echocardiograph will be available.

Keywords provided by Prof. dr. R.M.F. Berger, University Medical Center Groningen:
Incidence
Risk factors
Outcome

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Ventilator-Induced Lung Injury
Lung Injury
Bronchopulmonary Dysplasia
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases