Clinical trial NCT05006235: Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)
Official title: Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Transient Tachypnea of the Newborn
Keywords: Transient Tachypnea of the Newborn (TTN)
epinephrine
salbutamol
respiratory distress
newborn
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 135
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of oxygen support & O2 concentration until Downes' score less than 4
timeFrame: through study completion, about 1 year
Secondary outcomes:
measure: Length of hospital stay until Downes' score less than 4
timeFrame: through study completion, about 1 year
measure: Type of respiratory support (oxygen delivery and oxygen concentration)
timeFrame: within 12 hours after intervention
measure: Effect of intervention on blood sugar (mg/dl)
timeFrame: within 12 hours after intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Bertrand P, Aranibar H, Castro E, Sanchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. doi: 10.1002/ppul.1040.
citation: Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.
citation: Rawlings JS, Smith FR. Transient tachypnea of the newborn. An analysis of neonatal and obstetric risk factors. Am J Dis Child. 1984 Sep;138(9):869-71. doi: 10.1001/archpedi.1984.02140470067022.
citation: Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
citation: Vollsaeter M, Roksund OD, Eide GE, Markestad T, Halvorsen T. Lung function after preterm birth: development from mid-childhood to adulthood. Thorax. 2013 Aug;68(8):767-76. doi: 10.1136/thoraxjnl-2012-202980. Epub 2013 Jun 7.
citation: Yurdakok M. Transient tachypnea of the newborn: what is new? J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:24-6. doi: 10.3109/14767058.2010.507971.