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

NCT05006235 | Completed Phase 1

• 1 other identifier: MansouraUCH0321
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Transient Tachypnea of the Newborn

Keywords

Transient Tachypnea of the Newborn (TTN); epinephrine; salbutamol; respiratory distress; newborn

Outcome Measures

Primary Outcomes (1)

• Duration of oxygen support & O2 concentration until Downes' score less than 4

  through study completion, about 1 year

Secondary Outcomes (3)

• 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

Study Arms (3)

Salbutamol Group

ACTIVE COMPARATOR

included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline

Drug: Salbutamol

Epinephrine Group

ACTIVE COMPARATOR

included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline

Drug: Epinephrine Inhalation Solution

Saline Group

PLACEBO COMPARATOR

include babies who had received nebulized 0.9% saline

Drug: Saline Inhalants

Interventions

Epinephrine Inhalation Solution DRUG

Epinephrine Group

Salbutamol DRUG

Salbutamol Group

Saline Inhalants DRUG

Saline Group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Noaman: lead

Related Publications (6)

• 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.

  PMID: 11288210 BACKGROUND

• 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.

  PMID: 15605071 BACKGROUND

• 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.

  PMID: 6540983 BACKGROUND

• 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.

  PMID: 23736015 BACKGROUND

• 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.

  PMID: 23749815 BACKGROUND

• 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.

  PMID: 20807157 BACKGROUND

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Dyspnea

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 16, 2021
• Study Start: February 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: August 16, 2021

Record last verified: 2021-08