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Trial registered on ANZCTR


Registration number
ACTRN12614000674639
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
B-type Natriuretic Peptide and Occult Pulmonary Hypertension in Premature Infants
Scientific title
N-Terminal ProB-Type Natriuretic Peptide and Late Pulmonary Hypertension Secondary to Chronic Lung Disease in Premature Infants Born at Less Than 30 Weeks Gestation
Secondary ID [1] 284838 0
Nil
Universal Trial Number (UTN)
U1111-1158-2502
Trial acronym
BOPP
B-type natriuretic peptide and
Occult
Pulmonary hypertension in
Preterms
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension/pulmonary vascular disease 292229 0
Right Ventricular Dysfunction 292231 0
Premature Birth 292272 0
Chronic Lung Disease 292273 0
Condition category
Condition code
Respiratory 292566 292566 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 292630 292630 0 0
Complications of newborn
Cardiovascular 292631 292631 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
At 72 hours (end of day 3 of life), 240 hours (end of day 10), day 28 and 36 weeks infants will have blood NTpBNP levels measured and echocardiograms performed. Pulse oximetry data will be analysed for the time period approximately 72 hours prior to these tests.
Echocardiograms will be assessed for evidence of structural cardiac disease, cardiac dysfunction and evidence of raised pulmonary artery pressures. Pulse oximetry data will be analysed for time in target saturations, frequency and duration of hypoxic episodes and variability of oxygen saturation levels. Clinical data will be extracted by chart review. Respiratory health questionnaires will be sent to families at 1 and 2 years and clinical and neurodevelopment assessment performed at 2 years corrected age.
Intervention code [1] 289634 0
Not applicable
Comparator / control treatment
The evolution of the NTpBNP levels from 72 hours to 36 weeks will be compared across the recruited group of <30 week GA infants and compared to known reference ranges for preterm infants. There will also be subgroup analyses.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292428 0
Pulmonary hypertension (assessed by echocardiogram)
Timepoint [1] 292428 0
36 weeks post conceptual age
Secondary outcome [1] 308921 0
All cause mortality
Timepoint [1] 308921 0
36 weeks post conceptual age
Secondary outcome [2] 308922 0
Chronic lung disease defined according to NICHD definition: Mild BPD defined as a need for supplemental oxygen (O2) for > or =28 days but not at 36 weeks' postmenstrual age (PMA) or discharge .
Moderate BPD as O2 for > or =28 days plus treatment with <30% O2 at 36 weeks' PMA.
Severe BPD as O2 for > or =28 days plus > or =30% O2 and/or positive pressure at 36 weeks' PMA.
Timepoint [2] 308922 0
36 weeks post conceptual age
Secondary outcome [3] 308923 0
Duration of respiratory support
Timepoint [3] 308923 0
End of respiratory support
Secondary outcome [4] 308924 0
Duration of oxygen therapy
Timepoint [4] 308924 0
End of oxygen therapy
Secondary outcome [5] 308925 0
Echocardiographic evidence of cardiac dysfunction
Timepoint [5] 308925 0
Up to 36 weeks post conceptual age
Secondary outcome [6] 308926 0
Evidence of oxygen saturation instability as assessed by pulse oximetry data analysis.
Timepoint [6] 308926 0
Up to 36 weeks post conceptual age
Secondary outcome [7] 308927 0
Respiratory health after discharge form neonatal unit as assessed by respiratory health questionnaire(designed locally) and review of health records.
Timepoint [7] 308927 0
2 years (corrected age)
Secondary outcome [8] 308928 0
Neurodevelopmental outcome as assessed by Bayleys III scale.
Timepoint [8] 308928 0
Two years (corrected age)
Secondary outcome [9] 308929 0
Retinopathy of prematurity as assessed by ophthalmologist assessment.
Timepoint [9] 308929 0
Discharge from neonatal unit
Secondary outcome [10] 308930 0
Necrotising enterocolitis assessed by review of clinical notes using Bell Staging .
Timepoint [10] 308930 0
Discharge from neonatal unit.
Secondary outcome [11] 308931 0
Growth using routining collected growth parameters (weight, length and head circumference) with analysis of z scores in comparison to reference ranges.
Timepoint [11] 308931 0
Out to 36 weeks post conceptual age and at 2 years corrected age.

Eligibility
Key inclusion criteria
Infants born at < 30 weeks gestation and cared for at Christchurch Women's Hospital NICU.
Minimum age
1 Days
Maximum age
3 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known structural airway or lung anomalies, congenital anomalies of the pulmonary arteries or pulmonary veins, major systemic to pulmonary artery collateral vessels, congenital heart disease(except those with patent ductus arteriosus, patent foramen oval or atrial septal defect), severe liver disease and persistent pulmonary hypertension of the newborn (from birth).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There is very little published data on NTpBNP levels in preterm infants and the association with respiratory or cardiac outcomes. Based on the best available evidence estimates from standard power tables suggest that for this study to have 80% power to detect correlations in excess of 0.40 with alpha=0.05 we would require a minimum sample size of 45 infants. Allowing for potential sample loss due to failure to complete the full set of assessments we are aiming for a minimum target sample size of 50.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
12/03/2013
Date of last participant enrolment
Anticipated
1/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6163 0
New Zealand
State/province [1] 6163 0
Canterbury

Funding & Sponsors
Funding source category [1] 289449 0
Charities/Societies/Foundations
Name [1] 289449 0
Freemasons Paediatric Fellowship
Country [1] 289449 0
New Zealand
Funding source category [2] 289450 0
Charities/Societies/Foundations
Name [2] 289450 0
Maurice and Phyllis Paykel Trust
Country [2] 289450 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO BOX 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 288136 0
Individual
Name [1] 288136 0
Associate Professor Nicola Austin
Address [1] 288136 0
Clinical Director
Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country [1] 288136 0
New Zealand
Secondary sponsor category [2] 288137 0
Individual
Name [2] 288137 0
Professor Richard Troughton
Address [2] 288137 0
Department of Cardiology
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country [2] 288137 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291207 0
University of Otago Human Ethics Committee
Ethics committee address [1] 291207 0
Garry Witte
University of Otago Academic Committees Manager
Room G22 Clocktower Building
University of Otago
364 Leith Walk
Dunedin 9016
Ethics committee country [1] 291207 0
New Zealand
Date submitted for ethics approval [1] 291207 0
Approval date [1] 291207 0
23/11/2012
Ethics approval number [1] 291207 0
12/298

Summary
Brief summary
Infants born at < 28 weeks gestation have an underdeveloped cardiorespiratory system. Premature birth disrupts the development of the lungs and lung vasculature. Many infants are able to recover from this with supportive intensive care and time allowing fro growth and development. However there is increasing evidence from animal and human studies that a subgroup are at risk of abnormal pulmonary vascular development leading to a prolonged need for respiratory support and increased risk of death in the first two years of life. At present we lack good screening tools to identify infants at risk of abnormal pulmonary vascular development.

There is evidence from studies on animals, adults, children and term-born infants that B-type Natriuretic Peptide is elevated in the presence of pulmonary hypertension. Our hypothesis is that NTpBNP levels in extremely low gestational age neonates increase with increasing severity of lung disease and that those with the highest NTpBNP levels have the highest risk of recurrent hypoxemia (low oxygen levels). We also hypothesise that those with the highest late NTpBNP levels will demonstrate more cardiac dysfunction with evidence of raised pulmonary artery pressures in the most severely affected.

NTpBNP levels may help doctors to stratify premature infants into low, intermediate or high risk categories for the development of pulmonary hypertension and allow clinicians to identify those infants in need of further investigation. NTpBNP levels may also help identify which infants may benefit from medications that lower pulmonary pressures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49342 0
Dr Sarah Harris
Address 49342 0
Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 49342 0
New Zealand
Phone 49342 0
+64 3 3644885
Fax 49342 0
Email 49342 0
sarah.harris@otago.ac.nz
Contact person for public queries
Name 49343 0
Dr Sarah Harris
Address 49343 0
Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 49343 0
New Zealand
Phone 49343 0
+64 3 3644885
Fax 49343 0
Email 49343 0
sarah.harris@otago.ac.nz
Contact person for scientific queries
Name 49344 0
Dr Sarah Harris
Address 49344 0
Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 49344 0
New Zealand
Phone 49344 0
+64 3 3644885
Fax 49344 0
Email 49344 0
sarah.harris@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4481Study results articleYes Harris, S. L., More, K., Dixon, B., Troughton, R.,... [More Details]
4482Study results articleYes Harris, S. L., Troughton, R., Lewis, L., Austin, N... [More Details]
4483Study results articleYes Harris, S. L., Wolff, E., Beecroft, G., Troughton,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFactors affecting N-terminal pro-B-type natriuretic peptide levels in preterm infants and use in determination of haemodynamic significance of patent ductus arteriosus.2018https://dx.doi.org/10.1007/s00431-018-3089-y
N.B. These documents automatically identified may not have been verified by the study sponsor.