Determination of differential effects of 3 positions on lung function in preterm infants.

Positioning to improve lung function in preterm infants requiring ventilatory support.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000210572

Enrollment

Registered

2006-05-30

Start date

2005-08-11

Completion date

2006-10-26

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

Preterm infants are moved throughout different positions while nursed in the neonatal nursery. The aim of this study is to determine the effects of 3 commonly used positions on lung function in those infants requiring ventilatory support. The positions to be used include prone (lying on the stomach), supine (lying on the back), and ¼ turn from prone (lying on stomach with one side up). By looking at the ventilation distribution during positioning, this study will give clinicians an idea of how to optimise ventilation non-invasively using positioning. Factors we are investigating that are important in making this decision are optimal lung aeration and oxygenation. This trial will use recently developed scientific technology including lung scanning (EIT) and a new form of breath washout (MBW using sulphur hexafluoride) to give us a better understanding of the effectiveness of positioning. Data on EIT and MBW will be downloaded directly onto a computer and the data analyst will be blinded to the positions.

Interventions

Positioning - prone, supine, 1/4 prone. The infants rotate through the three different positions in a random order. Prior to the commencement of the study baseline measures are taken in the prone positiion. At 4 hourly intervals the baby is moved into the next nursing position with the study continuing for a total of 12 hours.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 28 Days

Healthy volunteers

Inclusion criteria

Neonates who:are heavier than 750 gramsare less than 32 weeks gestationare >24 hours of age have an arterial line in situ if mechanically ventilated.

Exclusion criteria

Cardiopulmonary instability not allowing position changesVentilated using high frequency oscillating ventilation (HFOV)Post surgical eg. Tracheoesophageal fistula, diaphragmatic hernia, gastroschisis, Spina BifidaKnown collapse/consolidation, or air leak syndrome (Pneumothorax, pulmonary interstitial emphysema)Poor skin integrityMothers under 18 years of age.

Outcome results