Clinical trial NCT05136235: Pulmonary Hypertension in Extremely Preterm Infants
Official title: Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Pulmonary Hypertension
Premature Birth
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
name: Universitaire Ziekenhuizen KU Leuven
name: GZA Ziekenhuizen Campus Sint-Augustinus
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Ziekenhuis Oost-Limburg
name: University Hospital, Ghent
First posted: 2021-11-29
Enrollment: 350
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Extremely preterm infants are at risk for developing bronchopulmonary dysplasia (BPD) and associated chronic pulmonary hypertension (PH), a consequence of altered pulmonary vasculature. This condition occurs in about 25% of babies with BPD, and the association grows with increasing BPD severity. Other risk factors have been described as well. Morbidity and mortality associated with prematurity and/or BPD increase significantly in the presence of PH.

Thus, international guidelines encourage the use of standardized screening protocols for this condition. However, several questions regarding these recommendations are left unanswered, such as a clear definition for PH in this population.

The research aim is to prospectively evaluate prevalence, risk factors and clinical course of PH in these children. The investigators aim to identify at-risk infants early on and ultimately improve survival making use of an early targeted intervention.


Eligibility criteria: Inclusion Criteria: Preterm infants with

* Gestational age \<28 0/7 weeks
* Birth weight \<1000 grams

Exclusion Criteria:

* Major congenital malformations
* Structural airway or lung disease
* Congenital heart disease
* Lack of parental consent

Primary outcomes:
measure: Presence of pulmonary hypertension
timeFrame: 3-10 days of life (time depending on the timing of the first echocardiography)
measure: Presence of pulmonary hypertension
timeFrame: at 28 days of life
measure: Presence of pulmonary hypertension
timeFrame: at 36 weeks PMA
measure: Presence of pulmonary hypertension
timeFrame: at 6 months of age
measure: Presence of pulmonary hypertension
timeFrame: at 12 months of age
Secondary outcomes:
measure: Presence of bronchopulmonary dysplasia
timeFrame: at 28 days of life
measure: Presence of bronchopulmonary dysplasia
timeFrame: at 36 weeks PMA
measure: Birth weight
timeFrame: at birth
measure: Gestational age
timeFrame: at birth
measure: Small for gestational age
timeFrame: at birth
measure: Oligohydramnios
timeFrame: at birth
measure: Maternal hypertensive disorders
timeFrame: at birth
measure: ROP
timeFrame: at 36 weeks
measure: NEC
timeFrame: at 36 weeks
measure: PDA
timeFrame: at 36 weeks
measure: Sepsis
timeFrame: up to discharge from the NICU, an average of 16 weeks
measure: VAP
timeFrame: at 36 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Barbara De Bisschop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Filip Cools, PhD
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Daniël De Wolf, PhD
role: STUDY_CHAIR
References:
citation: Arjaans S, Zwart EAH, Ploegstra MJ, Bos AF, Kooi EMW, Hillege HL, Berger RMF. Identification of gaps in the current knowledge on pulmonary hypertension in extremely preterm infants: A systematic review and meta-analysis. Paediatr Perinat Epidemiol. 2018 May;32(3):258-267. doi: 10.1111/ppe.12444. Epub 2018 Jan 17.
citation: Abman SH, Hansmann G, Archer SL, Ivy DD, Adatia I, Chung WK, Hanna BD, Rosenzweig EB, Raj JU, Cornfield D, Stenmark KR, Steinhorn R, Thebaud B, Fineman JR, Kuehne T, Feinstein JA, Friedberg MK, Earing M, Barst RJ, Keller RL, Kinsella JP, Mullen M, Deterding R, Kulik T, Mallory G, Humpl T, Wessel DL; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; and the American Thoracic Society. Pediatric Pulmonary Hypertension: Guidelines From the American Heart Association and American Thoracic Society. Circulation. 2015 Nov 24;132(21):2037-99. doi: 10.1161/CIR.0000000000000329. Epub 2015 Nov 3.
citation: Hilgendorff A, Apitz C, Bonnet D, Hansmann G. Pulmonary hypertension associated with acute or chronic lung diseases in the preterm and term neonate and infant. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK. Heart. 2016 May;102 Suppl 2:ii49-56. doi: 10.1136/heartjnl-2015-308591.
citation: Krishnan U, Feinstein JA, Adatia I, Austin ED, Mullen MP, Hopper RK, Hanna B, Romer L, Keller RL, Fineman J, Steinhorn R, Kinsella JP, Ivy DD, Rosenzweig EB, Raj U, Humpl T, Abman SH; Pediatric Pulmonary Hypertension Network (PPHNet). Evaluation and Management of Pulmonary Hypertension in Children with Bronchopulmonary Dysplasia. J Pediatr. 2017 Sep;188:24-34.e1. doi: 10.1016/j.jpeds.2017.05.029. Epub 2017 Jun 20. No abstract available.
citation: Levy PT, Jain A, Nawaytou H, Teitel D, Keller R, Fineman J, Steinhorn R, Abman SH, McNamara PJ; Pediatric Pulmonary Hypertension Network (PPHNet). Risk Assessment and Monitoring of Chronic Pulmonary Hypertension in Premature Infants. J Pediatr. 2020 Feb;217:199-209.e4. doi: 10.1016/j.jpeds.2019.10.034. Epub 2019 Nov 14. No abstract available.