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Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Z

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase

Completed
Phase 4

Conditions

Meconium Aspiration Syndrome

Treatments

Drug: Lung lavage with surfactant
Drug: Bolus surfactant

Study type

Interventional

Funder types

Other

Identifiers

NCT02041546
ZTB0607

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Bolus surfactant
Active Comparator group
Description:
Bolus surfactant 100 mg/kg proctant alfa
Treatment:
Drug: Bolus surfactant
Lung lavage with surfactant
Active Comparator group
Description:
Lung lavage with surfactant
Treatment:
Drug: Lung lavage with surfactant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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