Transient Tachypnea of the Newborn
Conditions
Keywords
Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn
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.
Interventions
Sponsors
Ahmed Noaman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 6 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of oxygen support & O2 concentration until Downes' score less than 4 | through study completion, about 1 year |
Secondary
| Measure | 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 |
Outcome results
None listed