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Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Primary Purpose

Meconium Aspiration Syndrome

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Lung lavage with surfactant

Bolus surfactant

About this trial

This is an interventional treatment trial for Meconium Aspiration Syndrome focused on measuring Lung lavage,, Surfactant,, Duration of mechanical, ventilation

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept 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

Sites / Locations

Zekai Tahir Burak Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bolus surfactant

Lung lavage with surfactant

Arm Description

Bolus surfactant 100 mg/kg proctant alfa

Lung lavage with surfactant

Outcomes

Primary Outcome Measures

Duration of mechanical ventilation

Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

Secondary Outcome Measures

Complications

Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.

Duration of Hospital Stay

We will record length of stay in a level III neonatal intensive care unit.

Mortality

We will record who died until discharge.

Full Information

NCT ID

NCT02041546

First Posted

January 15, 2014

Last Updated

August 2, 2016

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02041546

Brief Title

Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

Official Title

Zekai Tahir Burak Maternity Teaching Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meconium Aspiration Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bolus surfactant

Arm Type

Active Comparator

Arm Description

Bolus surfactant 100 mg/kg proctant alfa

Arm Title

Lung lavage with surfactant

Arm Type

Active Comparator

Arm Description

Lung lavage with surfactant

Intervention Type

Drug

Intervention Name(s)

Lung lavage with surfactant

Other Intervention Name(s)

Poractant alfa

Intervention Type

Drug

Intervention Name(s)

Bolus surfactant

Other Intervention Name(s)

Poractant alfa

Primary Outcome Measure Information:

Title

Duration of mechanical ventilation

Description

Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.

Time Frame

up to 2 weeks

Secondary Outcome Measure Information:

Title

Complications

Description

Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.

Time Frame

up to 4 weeks

Title

Duration of Hospital Stay

Description

We will record length of stay in a level III neonatal intensive care unit.

Time Frame

Up to 8 weeks or till discharge

Title

Mortality

Description

We will record who died until discharge.

Time Frame

Up to 3 months or till discharge

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Zekai Tahir Burak Maternity Teaching Hospital

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

30690595

Citation

Arayici S, Sari FN, Kadioglu Simsek G, Yarci E, Alyamac Dizdar E, Uras N, Canpolat FE, Oguz SS. Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome. J Trop Pediatr. 2019 Oct 1;65(5):491-497. doi: 10.1093/tropej/fmy081.

Results Reference

derived

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Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome

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