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

Ahmed Noaman135 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

135

Conditions

Transient Tachypnea of the Newborn

Interventions

Epinephrine Inhalation SolutionDRUG

SalbutamolDRUG

Saline InhalantsDRUG

Eligibility

Sex: ALLMin age: 1 HourMax age: 6 Hours

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Duration of oxygen support & O2 concentration until Downes' score less than 4

Time frame: through study completion, about 1 year

Secondary Outcomes

Length of hospital stay until Downes' score less than 4

Time frame: through study completion, about 1 year

Type of respiratory support (oxygen delivery and oxygen concentration)

Time frame: within 12 hours after intervention

Effect of intervention on blood sugar (mg/dl)

Time frame: within 12 hours after intervention

Data from ClinicalTrials.gov

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