Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2015-12-31

Brief Summary

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Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:

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Detailed Description

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This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study.

Conditions

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Transient Tachypnea of the Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Salbutamol Group

included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline

Group Type ACTIVE_COMPARATOR

Salbutamol

Intervention Type DRUG

Epinephrine Group

included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline

Group Type ACTIVE_COMPARATOR

Epinephrine Inhalation Solution

Intervention Type DRUG

Saline Group

include babies who had received nebulized 0.9% saline

Group Type PLACEBO_COMPARATOR

Saline Inhalants

Intervention Type DRUG

Interventions

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Epinephrine Inhalation Solution

Intervention Type DRUG

Salbutamol

Intervention Type DRUG

Saline Inhalants

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:

* Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth
* Persistence of tachypnea for at least 12 hours
* Mild cyanosis, nasal flaring, or retractions.
* Chest radiograph indicating at least one of the following:
* Prominent central vascular markings
* Widened interlobar fissures
* Symmetrical perihilar congestion
* Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.

Exclusion Criteria

* Newborn infants with gestational age \< 35 weeks
* Meconium aspiration
* Respiratory distress syndrome
* Pneumonia
* Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
* Sepsis or suspected sepsis
* Polycythemia
* Newborn infants with congenital malformations and chromosomal anomalies
* Newborn infants with ventilatory support.
* Newborn infants with arrhythmia

Minimum Eligible Age

1 Hour

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No