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A pilot study to compare high versus low tidal volume for mechanical ventilation in preterm babies with respiratory distress syndrome

HILO Trial - A comparative pilot study of HIgh versus LOw tidal volume for mechanical ventilation in very low birth weight preterm babies with respiratory distress syndrome. A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86307399
Enrollment
70
Registered
2014-08-14
Start date
2013-07-18
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Respiratory distress syndrome Respiratory Respiratory distress syndrome of newborn

Interventions

The study would involve randomising the babies to low tidal volume (4-5 ml/kg) or high tidal volume (7-8 ml/kg) at birth using volume guarantee mode of ventilation. We would also collect tracheal aspi

Sponsors

North Tees and Hartlepool Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm babies weighing 500-1500g or =32 weeks of gestation at birth 2. Requirement of intubation and mechanical ventilation

Exclusion criteria

Exclusion criteria: 1. Serious underlying congenital anomaly 1.1. Congenital diaphragmatic hernia 1.2. Cyanotic congenital heart disease 1.3. Airway anomalies 1.4. Abdominal wall defects 2. Multiple pregnancies ? only the first-born were enrolled and randomized; the others received the same strategy but were not be enrolled 3. Babies initiated on ventilation after 12 hours of life or transferred from other centres

Design outcomes

Primary

MeasureTime frame
The time to achieve 25% reduction in peak pressure

Secondary

MeasureTime frame
1. Duration of intubation 2.Incidence of pulmonary and non-pulmonary complications i.e., pneumothorax, bronchopulmonary dyplasia, intraventricular haemorrhage 3. Impact on inflammatory markers in tracheal aspirate 4. Survival to discharge

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026