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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]

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

Right Ventricular Dysfunction

Premature Birth

Chronic Lung Disease

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

Complications of newborn

Cardiovascular

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]

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]

Pulmonary hypertension (assessed by echocardiogram)

Timepoint [1]

36 weeks post conceptual age

Secondary outcome [1]

All cause mortality

Timepoint [1]

36 weeks post conceptual age

Secondary outcome [2]

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]

36 weeks post conceptual age

Secondary outcome [3]

Duration of respiratory support

Timepoint [3]

End of respiratory support

Secondary outcome [4]

Duration of oxygen therapy

Timepoint [4]

End of oxygen therapy

Secondary outcome [5]

Echocardiographic evidence of cardiac dysfunction

Timepoint [5]

Up to 36 weeks post conceptual age

Secondary outcome [6]

Evidence of oxygen saturation instability as assessed by pulse oximetry data analysis.

Timepoint [6]

Up to 36 weeks post conceptual age

Secondary outcome [7]

Respiratory health after discharge form neonatal unit as assessed by respiratory health questionnaire(designed locally) and review of health records.

Timepoint [7]

2 years (corrected age)

Secondary outcome [8]

Neurodevelopmental outcome as assessed by Bayleys III scale.

Timepoint [8]

Two years (corrected age)

Secondary outcome [9]

Retinopathy of prematurity as assessed by ophthalmologist assessment.

Timepoint [9]

Discharge from neonatal unit

Secondary outcome [10]

Necrotising enterocolitis assessed by review of clinical notes using Bell Staging .

Timepoint [10]

Discharge from neonatal unit.

Secondary outcome [11]

Growth using routining collected growth parameters (weight, length and head circumference) with analysis of z scores in comparison to reference ranges.

Timepoint [11]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Freemasons Paediatric Fellowship

Address [1]

Administered through:
University of Otago
(364 Leith Walk)
PO BOX 56
Dunedin 9054

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Maurice and Phyllis Paykel Trust

Address [2]

PO BOX 37760
Parnell
Auckland 1151

Country [2]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO BOX 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Nicola Austin

Address [1]

Clinical Director
Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Professor Richard Troughton

Address [2]

Department of Cardiology
Christchurch Hospital
Private Bag 4710
Christchurch 8140

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

Garry Witte 
University of Otago Academic Committees Manager
Room G22 Clocktower Building
University of Otago
364 Leith Walk
Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

23/11/2012

Ethics approval number [1]

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

Dr Sarah Harris

Address

Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644885

Fax

[email protected]

Contact person for public queries

Name

Sarah Harris

Address

Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644885

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Harris

Address

Neonatal Unit
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644885

Fax

[email protected]

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

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Harris, S. L., More, K., Dixon, B., Troughton, R.,... [More Details]
Study results article	Yes	Harris, S. L., Troughton, R., Lewis, L., Austin, N... [More Details]
Study results article	Yes	Harris, S. L., Wolff, E., Beecroft, G., Troughton,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Factors affecting N-terminal pro-B-type natriuretic peptide levels in preterm infants and use in determination of haemodynamic significance of patent ductus arteriosus.	2018	https://dx.doi.org/10.1007/s00431-018-3089-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically