RecruitingACTRN12614000674639

B-type Natriuretic Peptide and Occult Pulmonary Hypertension in Premature Infants

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


Sponsor

University of Otago

Enrollment

50 participants

Start Date

Mar 12, 2013

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 3 Dayss

Plain Language Summary

Simplified for easier understanding

Babies born very prematurely (before 30 weeks of pregnancy) are at risk of developing high pressure in the blood vessels of the lungs (pulmonary hypertension) as they grow. Currently, there is no good early test to identify which premature babies are most at risk. This study is testing whether a blood marker called NTpBNP — which is elevated in adults with pulmonary hypertension — can help doctors identify premature newborns who may need closer monitoring and treatment. You may be eligible if: - Your baby was born before 30 weeks of gestation - Your baby is receiving care in the NICU at Christchurch Women's Hospital You may NOT be eligible if: - Your baby has a known structural lung or airway problem - Your baby has congenital heart disease (other than patent ductus arteriosus, patent foramen ovale, or small atrial septal defect) - Your baby has severe liver disease - Your baby has been diagnosed with persistent pulmonary hypertension from birth Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 fo

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.


Locations(1)

Canterbury, New Zealand

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