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Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Zekai Tahir Burak Maternity Teaching Hospital

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02041546
Enrollment
30
Registered
2014-01-22
Start date
2013-09-30
Completion date
2014-12-31
Last updated
2016-08-03

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

Conditions

Meconium Aspiration Syndrome

Keywords

Lung lavage,, Surfactant,, Duration of mechanical, ventilation

Brief summary

Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.

Interventions

DRUGLung lavage with surfactant
DRUGBolus surfactant

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
No minimum to 7 Days
Healthy volunteers
No

Inclusion criteria

* Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.

Exclusion criteria

* Congenital cardiac anomalies * Major congenital anomalies * Hemodynamically unstable infants

Design outcomes

Primary

MeasureTime frameDescription
Duration of mechanical ventilationup to 2 weeksTotal duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

Secondary

MeasureTime frameDescription
Complicationsup to 4 weeksIncidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.
Duration of Hospital StayUp to 8 weeks or till dischargeWe will record length of stay in a level III neonatal intensive care unit.
MortalityUp to 3 months or till dischargeWe will record who died until discharge.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026