Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-12

Study Completion Date

2024-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

NCT00312507

Meconium Aspiration Syndrome

UNKNOWN PHASE3

Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies

NCT01758822

Meconium Aspiration Syndrome

COMPLETED NA

Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS

NCT02482766

Respiratory Distress Syndrome Hyaline Membrane Disease

COMPLETED NA

Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation

NCT01306240

Acute Respiratory Distress Syndrome

TERMINATED PHASE3

Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates

NCT02774044

Respiratory Distress Syndrome

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care

Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life.

Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meconium Aspiration Syndrome Surfactant Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early bolus surfactant replacement therapy

Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life

Group Type EXPERIMENTAL

Bovine surfactant

Intervention Type DRUG

Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg

Standard care

Neonates randomized to this group will be managed as per standard protocol in the neonatal unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bovine surfactant

Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gestation age ≥ 37 week
* Cephalic presentation
* Singleton pregnancy
* Age \< 2 hours
* Baby delivered through meconium stained amniotic fluid
* Presence of respiratory distress (DOWNE's score ≥4)