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Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome

Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03400670
Acronym
(NCPAP)
Enrollment
400
Registered
2018-01-17
Start date
2017-01-05
Completion date
2020-02-05
Last updated
2019-07-16

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

Conditions

Ventilatory Failure

Keywords

NCPAP, Respiratory Distress Syndrome

Brief summary

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Detailed description

Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 \<0.30. Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30. Non-invasive respiratory support failure is set as follows: * FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher, * Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation, * Persistent acidosis; presence of pH \< 7.20 and PCO2 \> 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis, * Severe respiratory distress, * Pulmonary haemorrhage and cardiopulmonary arrest.

Interventions

infants will be randomized into two different NCPAP groups

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Hours
Healthy volunteers
No

Inclusion criteria

* Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

Exclusion criteria

* Major congenital anomalies * Presence of cardiovascular instability * Intubation at admission to the NICU * Consent not provided or refused

Design outcomes

Primary

MeasureTime frameDescription
noninvasive ventilation failure72 hoursneed for mechanical ventilation in the first 72 hours of life

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet Büyüktiryaki, MD
mbuyuktiryaki@yahoo.com+905054525576
Backup ContactSuna Oguz
serifesuna@gmail.com+90 3123065270

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026