Neolifes Heart – Pulmonary Hypertension in Preterm Children

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Brief Title

Neolifes Heart - Pulmonary Hypertension in Preterm Children

Official Title

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

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.
    

Detailed Description

      Background:

      The development is not complete in premature born children. For example, the lungs are not
      fully developed. This is associated with shortness of breath and an increased oxygen need.
      Some of these children will need ventilation support and develop the condition
      Bronchopulmonary dysplasia (BPD). BPD is considered with lung injury and more than 28 days of
      ventilation support. These children have more need for oxygen and are extra sensitive for
      infections. In the present era, BPD most often occurs in extremely premature infants born at
      24-28 weeks' post menstrual age, who have showed less severe acute respiratory symptoms and
      require less respiratory support than BPD patients have traditionally had in the past.
      Histological examination of these 'new BPD' patients suggests that the extreme preterm birth
      in combination with perinatal lung injury affects the normal growth of the lung development,
      resulting in disrupted vascular growth and impaired alveolarization, which could result in
      PH, a high blood pressure in the lungs. The causal relation among prenatal factors,
      prematurity, BPD and PH are not fully known yet. In premature newborns, < 30 weeks, the
      prevalence of BPD has been estimated to be 30-60% , while the prevalence of occurrence of PH
      received significantly less attention and estimates vary from 18% in the total group and up
      to 30% in the BPD-group and 50% in the severe BPD-group. The development of PH complicates
      the postnatal course of extreme premature infants. Both early and late PH are associated with
      poor outcomes among preterm infants, with and without BPD. Recent reports suggests that
      morbidity and late mortality of PH in the 'new BPD' is high, with up to 48% mortality 2 years
      after diagnosis of PH. The pathogenesis of BPD is complex and known risk factors for the
      development of severe BPD includes maternal and neonatal factors, such as childbearing
      history, male gender, smoking mother during pregnancy, chorioamnionitis, low-birth-weight,
      gestational age, cholestasis and acute lung injury by high ventilator settings. Risk factors
      for the development of PH in extreme preterm infants are not well defined. Knowledge of
      prevalence and risk factors of PH in extreme premature infants will allow evidence-based
      screening guidelines for the infants. Also potentially leading to prevention of this
      complicating condition in the future, since an earlier intervention will be possible under
      guidance of known risk factors. Early detection will lead to early and thus potentially
      better treatment of PH in preterm born infants.

      Objective of the study:

      Primary:

      To identify the incidence and prevalence of PH in premature born infants with and without BPD
      in the first year of life.

      Secondary:

      To identify risk factors for the development of PH in these patients To characterize
      morbidity and survival of these patients during the first 2 yrs of life.

      Study design:

      Prospective Observational Cohort study. Inclusion 2016-2018, Follow up for standardized care
      (including QoL) at: 6, 12 and 24 months corrected age.

      For Neolifes-Heart: echocardiography and transcutaneous oxygen measurement will be performed
      at: 1) first week after birth, 2) 3 months corrected age, 3) 12 months corrected age.

      Study population:

      All premature infants, admitted at the neonatology UMCG, born <30 weeks or birth weight <
      1000 gram, who participate in NeolifeS. Only children whom parents have given written
      informed consent are included in this study.

      Primary study parameter:

      The echocardiographic presence of PH (incidence and point-prevalence).

      Secondary study parameters:

      Morbidity, Mortality: Quality of life questionnaire and survival. Maternal factors: mode of
      conception, delivery, preterm premature rupture of membranes (PROM), maternal disease
      history, illnesses during gestation, tabacco and medication use. Perinatal variables: slow
      growth patterns in utero, prenatal echo findings, PROM, chorioamnionitis, oligohydramnios,
      birth events, placental histology. Neonatal variables: development of BPD, low birth weight,
      gestational age, skull circumference, pulmonary and artificial ventilation variables, oxygen
      need, presence of persistent arterial duct (PDA), medication, infections, renal function,
      complications (NEC), slow growth at gestational age (GA) 36wks and at discharge. other:
      demographics, slow growth, admissions, medication, feeding, neurological development,
      respiratory symptoms, lung clearing index.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Incidence of pulmonary hypertension

Secondary Outcome

 Mortality

Condition

Pulmonary Hypertension


Study Arms / Comparison Groups

 Neolifes Heart
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

165

Start Date

June 2016

Completion Date

April 2020

Primary Completion Date

April 2020

Eligibility 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
      

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Rolf Berger, +31641882427, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02729844

Organization ID

201500715


Responsible Party

Principal Investigator

Study Sponsor

University Medical Center Groningen


Study Sponsor

Rolf Berger, Principal Investigator, University Medical Center Groningen


Verification Date

October 2019