Neolifes Heart - Pulmonary Hypertension in Preterm Children

NCT02729844 | Completed DMC

• 1 other identifier: 201500715
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Bronchopulmonary Dysplasia

Keywords

Incidence; Risk factors; Outcome

Outcome Measures

Primary Outcomes (1)

• Incidence of pulmonary hypertension

  at 12 months corrected age.

Secondary Outcomes (2)

• Mortality

  At 12 months corrected age.

• Morbidity

  at 12 months corrected age

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (13)

• Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.

  PMID: 5334613 BACKGROUND

• Bancalari E, Claure N. Definitions and diagnostic criteria for bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):164-70. doi: 10.1053/j.semperi.2006.05.002.

  PMID: 16860155 BACKGROUND

• Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.

  PMID: 11401896 BACKGROUND

• Mourani PM, Sontag MK, Younoszai A, Miller JI, Kinsella JP, Baker CD, Poindexter BB, Ingram DA, Abman SH. Early pulmonary vascular disease in preterm infants at risk for bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2015 Jan 1;191(1):87-95. doi: 10.1164/rccm.201409-1594OC.

  PMID: 25389562 BACKGROUND

• Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.

  PMID: 22240409 BACKGROUND

• Khemani E, McElhinney DB, Rhein L, Andrade O, Lacro RV, Thomas KC, Mullen MP. Pulmonary artery hypertension in formerly premature infants with bronchopulmonary dysplasia: clinical features and outcomes in the surfactant era. Pediatrics. 2007 Dec;120(6):1260-9. doi: 10.1542/peds.2007-0971.

  PMID: 18055675 BACKGROUND

• Bhat R, Salas AA, Foster C, Carlo WA, Ambalavanan N. Prospective analysis of pulmonary hypertension in extremely low birth weight infants. Pediatrics. 2012 Mar;129(3):e682-9. doi: 10.1542/peds.2011-1827. Epub 2012 Feb 6.

  PMID: 22311993 BACKGROUND

• Mourani PM, Abman SH. Pulmonary vascular disease in bronchopulmonary dysplasia: pulmonary hypertension and beyond. Curr Opin Pediatr. 2013 Jun;25(3):329-37. doi: 10.1097/MOP.0b013e328360a3f6.

  PMID: 23615175 BACKGROUND

• Van Marter LJ. Epidemiology of bronchopulmonary dysplasia. Semin Fetal Neonatal Med. 2009 Dec;14(6):358-66. doi: 10.1016/j.siny.2009.08.007. Epub 2009 Sep 26.

  PMID: 19783238 BACKGROUND

• Roofthooft MT, Elema A, Bergman KA, Berger RM. Patient characteristics in persistent pulmonary hypertension of the newborn. Pulm Med. 2011;2011:858154. doi: 10.1155/2011/858154. Epub 2011 May 24.

  PMID: 21660250 BACKGROUND

• Hilgendorff A, Reiss I, Ehrhardt H, Eickelberg O, Alvira CM. Chronic lung disease in the preterm infant. Lessons learned from animal models. Am J Respir Cell Mol Biol. 2014 Feb;50(2):233-45. doi: 10.1165/rcmb.2013-0014TR.

  PMID: 24024524 BACKGROUND

• D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.

  PMID: 1863023 BACKGROUND

• Ploegstra MJ, Roofthooft MT, Douwes JM, Bartelds B, Elzenga NJ, van de Weerd D, Hillege HL, Berger RM. Echocardiography in pediatric pulmonary arterial hypertension: early study on assessing disease severity and predicting outcome. Circ Cardiovasc Imaging. 2014 Dec 31;8(1):e000878. doi: 10.1161/CIRCIMAGING.113.000878. Print 2015 Jan.

  PMID: 25552488 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rolf Berger

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. R.M.F. Berger

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 6, 2016
• Study Start: June 1, 2016
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)