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

Transient Tachypnea of the Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006235
• Other study ID #: MansouraUCH0321
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: August 2021
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Drug:
• Epinephrine Inhalation Solution

• Salbutamol

• Saline Inhalants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Noaman

References & Publications (6)

Bertrand P, Araníbar H, Castro E, Sánchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. — View 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. — View 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. — View 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. — View Citation

Vollsæter M, Røksund 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. — View Citation

Yurdakök 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of oxygen support & O2 concentration until Downes' score less than 4		through study completion, about 1 year
Secondary	Length of hospital stay until Downes' score less than 4		through study completion, about 1 year
Secondary	Type of respiratory support (oxygen delivery and oxygen concentration)		within 12 hours after intervention
Secondary	Effect of intervention on blood sugar (mg/dl)		within 12 hours after intervention