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

August 7, 2021 updated by: Ahmed Noaman

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Salbutamol Group
included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline
Drug: Salbutamol
Active Comparator: Epinephrine Group
included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline
Drug: Epinephrine Inhalation Solution
Placebo Comparator: Saline Group
include babies who had received nebulized 0.9% saline
Drug: Saline Inhalants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of oxygen support & O2 concentration until Downes' score less than 4
Time Frame: through study completion, about 1 year
through study completion, about 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay until Downes' score less than 4
Time Frame: through study completion, about 1 year
through study completion, about 1 year
Type of respiratory support (oxygen delivery and oxygen concentration)
Time Frame: within 12 hours after intervention
within 12 hours after intervention
Effect of intervention on blood sugar (mg/dl)
Time Frame: within 12 hours after intervention
within 12 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Noaman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MansouraUCH0321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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