A Phase 4 interventional study of Neopuff; Fisher and Paykel, Auckland, New Zealand in Respiratory Distress Syndrome, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown. Open to participants aged Up to 3 Minutes. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Phase 4, Interventional, and Prevention
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.
Primary Outcome Measures:
Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures:
Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.
Group 2: Group that received nCPAP after birth. Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following SLI maneuver. If respiratory failure continues during nCPAP (such as apnea, gasping) and/or heart rate is > 60 / min but \< 100 / min , SLI maneuver will be repeated at the same pressure for the same time period. If heart rate > 60 / min but \<100 / min persists after the second SLI maneuver, resuscitation will be applied in line with the guidelines of American Academy of Pediatrics.
The control group of infants will receive nCPAP support at 5 cm H2O pressure and be supported in line with the guidelines of American Academy of Pediatrics.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room.
Device: Neopuff; Fisher and Paykel, Auckland, New Zealand
Preterm infants will be assisted in the delivery room without sustained lung inflation.
Device: Neopuff; Fisher and Paykel, Auckland, New Zealand
Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Also known as: SUSTAINED LUNG INFLATION MANEUVER
mechanical ventilation requirement
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Time frame: 72 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Zekai Tahir Burak Women's Health Research and Education Hospital