Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome

NCT01310621 | Completed DMC

• 1 other identifier: LHMC/2011/Sur-Lu-Lav
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium inhibits surfactant function directly and also decreases its synthesis by its toxic effects on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies with meconium aspiration. Surfactant replacement alone does not remove meconium from airways and multiple doses may be required .Therefore an effective therapy to improve outcome is crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by many pilot studies. So the investigators have decided to study the role surfactant lung lavage in the treatment of meconium aspiration syndrome.

Conditions

Meconium Aspiration Syndrome

Keywords

Neonate; Meconium aspiration syndrome; surfactant lung lavage

Outcome Measures

Primary Outcomes (3)

• duration of oxygen therapy in hours

  The duration of oxygen therapy, mode of delivery, FiO2 and flow rate will be documented hourly within first 2 hours before lavage and in post lavage- hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of oxygen therapy

  till discharge or death

• Severity of respiratory distress

  The severity of respiratory distress will be assessed using Downe's Score. These parameters will be documented hourly within first 2 hours before lavage and in post lavage hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of respiratory distress

  till discharge or death

• need for mechanical ventilation

  The babies will be assessed for the need for mechanical ventilation as per standard unit protocols.

  till discharge or death

Secondary Outcomes (5)

• Duration of mechanical ventilation

  till discharge or death

• Complications

  till discharge

• Incidence of sepsis

  till discharge

• Mortality

  till discharge

• Duration of Hospital stay

  till discharge

Study Arms (2)

No Lavage

NO INTERVENTION

Neonate randomized to this group will be managed as per the standard protocol in the neonatal ward. The evaluation of respiratory distress will be done using Downe's score at hourly intervals till 24 hrs, followed by 2 hourly intervals till 72 hrs and finally 4 hourly intervals till resolution of clinical distress.

Surfactant Lavage

EXPERIMENTAL

The diluted surfactant is instilled into endotracheal tube over a period of 15 to 20 seconds. Once the instillation is complete, 5 manual breaths will be provided and infant will be repositioned supine. The suction catheter will be inserted and advanced to a position approximately 5mm past the end of endotracheal tube. Suction will be activated for no more than 10 seconds and would be temporarily halted earlier if the oxygen saturation value falls by \> 5% of the prelavage value. The same shall be resumed once prelavage oxygen saturation has been restored. The infant's bed will now be moved back to horizontal position. Once the neonate is STABLE, suctioning will be again repeated. The total retrieved volume is measured and recorded.This procedure will be done in both right and left lateral decubitus position

Drug: Bovine surfactant

Interventions

Bovine surfactant DRUG

* Dose of diluted surfactant : 20ml/kg * Type :Bovine surfactant * Phospholipid concentration: 5 mg/ml * Number of lavages to be given: 2 (10ml/kg each)

Surfactant Lavage

Eligibility Criteria

• Age: 30 Minutes - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestation age ≥ 37 week
• Cephalic presentation
• Singleton pregnancy
• Presence of meconium stained amniotic fluid or staining of meconium in skin,umbilical cord or nails.
• Non vigorous babies
• Presence of respiratory distress(Downes score ≥4)
• Presence of meconium below vocal cords or chest x ray suggestive of meconium aspiration
• Age \< 2 hours

You may not qualify if:

• Major congenital malformations
• Congenital heart disease
• Hydrops fetalis
• Air leaks
• Pulmonary hemorrhage

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Sushma Nangia, MBBS, MD, DM

  Lady Hardinge Medical College, New Delhi, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

IN (1)