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

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

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.

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

Conditions
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Transient Tachypnea of the Newborn

Intervention / Treatment
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* Drug: Epinephrine Inhalation Solution
* Drug: Salbutamol
* Drug: Saline Inhalants


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of oxygen support & O2 concentration until Downes' score less than 4 |  | through study completion, about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn