Pulmonary HypertensionNCT02729844
Neolifes Heart - Pulmonary Hypertension in Preterm Children
An observational study of Pulmonary Hypertension and Bronchopulmonary Dysplasia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- How many people
- 134 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2016to 25 Aug 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All premature infants, admitted at the neonatology UMCG, born <30 weeks or birth weight < 1000 gram, who participate in NeolifeS
Who may be able to join
- All premature infants born <30 weeks or <100 gram
- admitted at the neonatology UMCG,
- participation in the study Neolifes
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Hypertension in Preterm Children Born at Gestational Age <30 Weeks: Prevalence, Risk Factors and Outcome
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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- Keywords
- Incidence, Risk factors, Outcome
- Medical subject headings
- Hypertension, Pulmonary, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pulmonary hypertension
Measured: at 12 months corrected age.
Secondary outcomes (2)
Mortality
survival
Measured: At 12 months corrected age.
Morbidity
Quality of life questionnaire
Measured: at 12 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start1 Jun 2016
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. R.M.F. Berger, University Medical Center Groningen
- Investigators
- Rolf Berger, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729844
- Sponsor's protocol ID
- 201500715
- Status last verified
- Nov 2021
- First submitted
- 21 Mar 2016
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Only in case of clinical need, the data of the echocardiograph will be available.
Publications
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.
PubMed 5334613Bancalari 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.
PubMed 16860155Jobe 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.
PubMed 11401896Mourani 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.
PubMed 25389562Berger 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.
PubMed 22240409Khemani 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.
PubMed 18055675Bhat 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.
PubMed 22311993Mourani 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.
PubMed 23615175Van 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.
PubMed 19783238Roofthooft 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.
PubMed 21660250Hilgendorff 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.
PubMed 24024524D'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.
PubMed 1863023Ploegstra 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.
PubMed 25552488
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension in Preterm Children Born at Gestational Age <30 Weeks: Prevalence, Risk Factors and Outcome
- ClinicalTrials.gov ID
- NCT02729844
- Acronym / sponsor ID
- 201500715
- Conditions
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- Keywords
- Incidence, Risk factors, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All premature infants, admitted at the neonatology UMCG, born <30 weeks or birth weight < 1000 gram, who participate in NeolifeS
Key inclusion criteria (3 listed)
- All premature infants born <30 weeks or <100 gram
- admitted at the neonatology UMCG,
- participation in the study Neolifes
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pulmonary hypertension
Time frame: at 12 months corrected age.
2 secondary outcomes
Mortality
Time frame: At 12 months corrected age.
Morbidity
Time frame: at 12 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Background: PubMed 5334613Northway 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.
- Background: PubMed 16860155Bancalari 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.
- Background: PubMed 11401896Jobe 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.
- Background: PubMed 25389562Mourani 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.
- Background: PubMed 22240409Berger 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.
- Background: PubMed 18055675Khemani 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.
- Background: PubMed 22311993Bhat 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.
- Background: PubMed 23615175Mourani 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.
- Background: PubMed 19783238Van 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.
- Background: PubMed 21660250Roofthooft 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.
- Background: PubMed 24024524Hilgendorff 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.
- Background: PubMed 1863023D'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.
- Individual participant dataSharing planned: No. Only in case of clinical need, the data of the echocardiograph will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Berger principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Bronchopulmonary Dysplasia, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pulmonary hypertension (time frame: at 12 months corrected age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729844, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.