Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
| Registry | NCT05006235 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, supportive care |
| Enrollment | 135 (Actual) |
| Sponsor | Ahmed Noaman (Other) |
| Conditions | Transient Tachypnea of the Newborn |
| Interventions | Epinephrine Inhalation Solution, Salbutamol, Saline Inhalants (Drug) |
| Dates | start 2014-02-01, primary completion 2015-12-31, completion 2015-12-31, first posted 2021-08-16, last updated 2021-08-16 |
Related Papers Related Patents Related Grants Related Experts
All trials for Transient Tachypnea of the Newborn All trials of Epinephrine Inhalation Solution All trials of Salbutamol
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Salbutamol Group | Active comparator | Drug: Salbutamol | included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline |
| Epinephrine Group | Active comparator | Drug: Epinephrine Inhalation Solution | included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline |
| Saline Group | Placebo comparator | Drug: Saline Inhalants | include babies who had received nebulized 0.9% saline |
Sex: All, ages: 1 Hour to 6 Hours
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