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

Phase 1

Completed

• Conditions: Transient Tachypnea of the Newborn
• Interventions: Drug: Saline Inhalants; Drug: Epinephrine Inhalation Solution; Drug: Salbutamol

• Registration Number: NCT05006235
• Lead Sponsor: Ahmed Noaman

Brief Summary

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

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 Timeline

• Study Start: 2014-02-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2021-07-21
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-07
• Last Update Submitted: 2021-08-07
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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