The effects of nasal continuous positive airway pressure on cardiac function in (i) premature infants with established lung disease and (ii) premature infants with minimal lung disease.

In preterm infants with a corrected gestational age of 28-34 weeks, do levels of nasal CPAP of 4 or 8 cm of water affect right ventricular cardiac output?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001057976

Enrollment

Registered

2011-10-10

Start date

2011-12-06

Completion date

2013-03-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to determine changes in blood flow in the heart associated with low or high air pressures given with the nasal prong breathing support to the prematurely born infant. Research studies have shown that nasal CPAP can influence the way the blood flows in premature infants. We want to find out if the CPAP machine affects the function of the heart and the blood flow to the lungs. So that we can learn what is the most appropriate level of CPAP for infants with different types of lung disease that provides respiratory support with least affect on heart function.

Interventions

nasal continuous positive airway pressure of 4, 6 and 8 centimeter of water for 15 minutes each in randomized order. There will be 5-10 minutes before changing to the next CPAP level to allow for echocardiographic assessment.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

28 Weeks to 34 Weeks

Healthy volunteers

Inclusion criteria

Premature infants with a corrected gestational age of 28-34 weeks, admitted to the Neonatal Intensive and Special Care and treated with nasal CPAP.

Exclusion criteria

Infants with sepsis, organ failure, necrotizing enterocolitis, seizures, or identified by the clinical team to be too sick to participate in the study will be excluded. Infants will be excluded if they have congenital heart disease including a haemodynamically significant patent ductus arteriosus (PDA), atrial septal defect (ASD)/persistent foramen ovale (PFO) and/or ventricular septal defect (VSD). Infants will also be excluded if they are treated with fractional inspired oxygen (FiO2) of more than 40%, and/or treated with a PEEP higher than 7 cmH2O, or nasal intermittent mandatory ventilation (nIMV).

Outcome results