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

Ahmed Noaman

Status and phase: Completed; Phase 1

Conditions: Transient Tachypnea of the Newborn

Treatments: Drug: Saline Inhalants; Drug: Epinephrine Inhalation Solution; Drug: Salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT05006235

MansouraUCH0321

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Salbutamol Group

Active Comparator group

Description:

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

Treatment:

Drug: Salbutamol

Epinephrine Group

Active Comparator group

Description:

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

Treatment:

Drug: Epinephrine Inhalation Solution

Saline Group

Placebo Comparator group

Description:

include babies who had received nebulized 0.9% saline

Treatment:

Drug: Saline Inhalants