In this research study we compare two approaches that can be used to give breathing support to prematurely born babies. Both techniques are currently used in different countries over the world. However, at this moment we don*t know which methods is…
ID
Source
Brief title
Condition
- Mental impairment disorders
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of death or bronchopulmonary dysplasia at 36 weeks gestation age.
Secondary outcome
Need for mechanical ventilation in the first 7 days of life
Need for surfactant
Neurodevelopment outcomes at 22-26 months of corrected age
Respiratory outcome at 22-26 months of corrected age
Background summary
Most prematurely born babies have difficulties with breathing and need help to
take their first breaths. The medical team will provide support for the
breathing and sometimes it is even necessary to place a breathing tube and to
use a breathing machine (intubation and ventilation). Because the lungs of
prematurely born babies are vulnerable, we try to avoid the need of intubation
and ventilation. For this reason, we initially give support with a breathing
mask that is placed over the mouth and nose of the baby. With his mask we give
breaths.
Study objective
In this research study we compare two approaches that can be used to give
breathing support to prematurely born babies. Both techniques are currently
used in different countries over the world. However, at this moment we don*t
know which methods is the best for prematurely born babies. We do know that
premature babies who need a breathing tube are at a greater risk for developing
chronic lung disease. A goal of this study is to find out which approach is
most able to reduce the risk of developing chronic lung disease.
Study design
Prospective, multicenter, single blinded, randomized, controlled trial
Intervention
Sustained inflation of 15 seconds with normal pressures (20cm H2O). If the
neonate doesn't respond (properly) on this, it will be given an extra sustained
inflation of 15 seconds with a slightly higher pressure (25 cm H2O).
Study burden and risks
Based on their prematurity both groups have a risk on pneumothorax. Based on
prior obtained research, this risk is not significantly different in both
groups.
Beide groepen hebben op basis van de prematuriteit een risico op een
pneumothorax. Gebaseerd op eerder verricht onderzoek is dit risico niet
significant verschillend voor beide groepen.
Center Drive, Building 31, Room 2a32 31
Bethesda, MD 20892 2425
US
Center Drive, Building 31, Room 2a32 31
Bethesda, MD 20892 2425
US
Listed location countries
Age
Inclusion criteria
Infants born in participating Neonatal Intensive Care Units
Gestational Age at least 23 weeks but less than 27 completed weeks
requiring resuscitation/respiratory intervention at birth
Exclusion criteria
Considered non-viable by the attending neonatologist
Refusal of antenal informed consent
Known major anomalities, pulmonary hypoplasia
Mothers who are uable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02139800 |
| CCMO | NL49810.058.14 |