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NCT Number: NCT05006235

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

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

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Key information

Conditions

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

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrine Inhalation Solution

Drug

Salbutamol

Drug

Saline Inhalants

Drug

Primary outcomes

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

    Time frame: through study completion, about 1 year

Secondary outcomes

  1. Length of hospital stay until Downes' score less than 4

    Time frame: through study completion, about 1 year

  2. Type of respiratory support (oxygen delivery and oxygen concentration)

    Time frame: within 12 hours after intervention

  3. Effect of intervention on blood sugar (mg/dl)

    Time frame: within 12 hours after intervention

Sponsors and collaborators

Lead sponsor

Ahmed Noaman

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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