Skip to content

Gerandomiseerde studie naar het monitoren van longfunctie bij de opvang van te vroeg geborenen bij de geboorte

A randomized controlled trial of respiratory function monitoring during stabilization of preterm infants at birth

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23993
Enrollment
320
Registered
2013-08-02
Start date
2013-09-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

prematuriteit- prematurity resuscitatie-resuscitation

Interventions

At birth positive pressure ventilation will be given with or without the guidance if a respiratory function monitor. The display of the monitor will be visible or covered.

Sponsors

Leids Universitair Medisch Centrum, Leiden, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants born will be included in this study if they are between 24 and 27 completed weeks gestation receiving PPV for resuscitation at birth and do not have a known abnormality which might interfere with breathing.

Exclusion criteria

Exclusion criteria: Infants will be excluded from the final analysis if they are found to have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia, tracheo-oesophageal fistula or cyanotic heart disease.

Design outcomes

Secondary

MeasureTime frame
- Rates of endotracheal intubation in the first 24 hours after birth - The need for circulatory support over first 24 hours (inotropes and fluid boluses) - Incidence of air leak (pneumothorax, pulmonary interstitial emphysema,or pneumomediastinum) in the first 72 hours, reported by a radiologist masked to the intervention. - Incidence of abnormal cranial ultrasound findings (i) all intraventricular haemorrhage, (ii) severe – ie. Papile grade III and IV intraventricular haemorrhage, (iii) periventricular leukomalacia - Duration of endotracheal (ET) ventilation (hours). - Duration of nasal CPAP (hours). - Duration of supplemental oxygen therapy (hours) - Total duration of assisted ventilation (ET, CPAP) in hours - Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support. The severity of BPD will be assessed as proposed by Jobe et al.34 and oxygen reduction test will be performed in case of moderate BPD as described by Walsh et al35. - Neonatal mortality - death before discharge from hospital. - Composite outcome of death or BPD

Primary

MeasureTime frame
The proportion of tidal volumes delivered during manual PPV to an infant within the target range of safe tidal ventilation. The target range of adequate tidal volume is defined as 4-8 mL/kg.

Contacts

Public ContactArjan B. Pas, te

Leiden University Medical Center (LUMC), J6-S, Department of Pediatrics, P.O. Box 9600

a.b.te_pas@lumc.nl+31 (0)71 5262909

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)