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Clinical Trials/NL-OMON32906
NL-OMON32906
Completed
Phase 3

asal Intermittent Positive Pressure Ventilation for Premature Infants - NIPPV-trial

niversitair Medisch Centrum Groningen0 sites170 target enrollmentTBD
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ConditionsBronchopulmonary dysplasiaChronic Lung DiseaseRespiratory Distress10028971

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Bronchopulmonary dysplasia
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
170
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Gestational age less than 30 weeks
  • •Birthweight less than 1 kg
  • •Intention to manage the infant with non\-invasive respiratory support (i.e. no endotracheal tube) whether
  • •A. primairy: within the first 7 days of life and the infant has never been intubated or has received less than 24 hours of intubated respiratory support (e.g. for endotracheal surfactant therapy /INSURE:intubate\-surfactant replacement therapy\-extubate)
  • •B. secondary:the infant is within the first 28 days of life, has been managed with intubated respiratory support for more than 24 hours and is a candidate for extubation followed by non\-invasive respiratory support.

Exclusion Criteria

  • •1\. Considered Non\-viable by attending physician
  • •2\. Life\-threatening congenital abnormalties including congenital heart disease (exl patent ductus arteriosus)
  • •3\. Infants known to require surgical treatmene e.g. congenital diaphragmatic hernia, tracheo\-oesophageal fistula, omphalocele and gastroschisis.
  • •4\. Abnormalties of the upper and lower airways; such as Pierre\-Robin sequence, Treacher Collins syndrome, Goldenhar syndrome, cleft lips and palate.
  • •5\. Neuromuscular disorders.

Outcomes

Primary Outcomes

Not specified

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