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

Primary Purpose

Transient Tachypnea of the Newborn

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Epinephrine Inhalation Solution
Salbutamol
Saline Inhalants
Sponsored by
Ahmed Noaman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Transient Tachypnea of the Newborn focused on measuring Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn

Eligibility Criteria

1 Hour - 6 Hours (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Salbutamol Group

    Epinephrine Group

    Saline Group

    Arm Description

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

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

    include babies who had received nebulized 0.9% saline

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Length of hospital stay until Downes' score less than 4
    Type of respiratory support (oxygen delivery and oxygen concentration)
    Effect of intervention on blood sugar (mg/dl)

    Full Information

    First Posted
    July 21, 2021
    Last Updated
    August 7, 2021
    Sponsor
    Ahmed Noaman
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05006235
    Brief Title
    Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)
    Official Title
    Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2014 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    December 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ahmed Noaman

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transient Tachypnea of the Newborn
    Keywords
    Transient Tachypnea of the Newborn (TTN), epinephrine, salbutamol, respiratory distress, newborn

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    135 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Salbutamol Group
    Arm Type
    Active Comparator
    Arm Description
    included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline
    Arm Title
    Epinephrine Group
    Arm Type
    Active Comparator
    Arm Description
    included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline
    Arm Title
    Saline Group
    Arm Type
    Placebo Comparator
    Arm Description
    include babies who had received nebulized 0.9% saline
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine Inhalation Solution
    Intervention Type
    Drug
    Intervention Name(s)
    Salbutamol
    Intervention Type
    Drug
    Intervention Name(s)
    Saline Inhalants
    Primary Outcome Measure Information:
    Title
    Duration of oxygen support & O2 concentration until Downes' score less than 4
    Time Frame
    through study completion, about 1 year
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay until Downes' score less than 4
    Time Frame
    through study completion, about 1 year
    Title
    Type of respiratory support (oxygen delivery and oxygen concentration)
    Time Frame
    within 12 hours after intervention
    Title
    Effect of intervention on blood sugar (mg/dl)
    Time Frame
    within 12 hours after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Hour
    Maximum Age & Unit of Time
    6 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11288210
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15605071
    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. doi: 10.1038/sj.jp.7211242.
    Results Reference
    background
    PubMed Identifier
    6540983
    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. doi: 10.1001/archpedi.1984.02140470067022.
    Results Reference
    background
    PubMed Identifier
    23736015
    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.
    Results Reference
    background
    PubMed Identifier
    23749815
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20807157
    Citation
    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.
    Results Reference
    background

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

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