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

Sponsor

Ahmed Noaman (Other)

Overall Status

Completed

CT.gov ID

NCT05006235

Collaborator

(none)

135

Enrollment

Arms

22.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn:

Randomized controlled trial to assess:

Condition or Disease	Intervention/Treatment	Phase
Transient Tachypnea of the Newborn	Drug: Epinephrine Inhalation Solution Drug: Salbutamol Drug: Saline Inhalants	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Salbutamol Group included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline	Drug: Salbutamol
Active Comparator: Epinephrine Group included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline	Drug: Epinephrine Inhalation Solution
Placebo Comparator: Saline Group include babies who had received nebulized 0.9% saline	Drug: Saline Inhalants

Arm

Intervention/Treatment

Active Comparator: Salbutamol Group

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

Drug: Salbutamol

Active Comparator: Epinephrine Group

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

Drug: Epinephrine Inhalation Solution

Placebo Comparator: Saline Group

include babies who had received nebulized 0.9% saline

Drug: Saline Inhalants

Outcome Measures

Primary Outcome Measures

Duration of oxygen support & O2 concentration until Downes' score less than 4 [through study completion, about 1 year]

Secondary Outcome Measures

Length of hospital stay until Downes' score less than 4 [through study completion, about 1 year]
Type of respiratory support (oxygen delivery and oxygen concentration) [within 12 hours after intervention]
Effect of intervention on blood sugar (mg/dl) [within 12 hours after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 6 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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