Transient Tachypnea of the Newborn Clinical Trial
Official title:
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
Verified date | August 2021 |
Source | Mansoura University Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:
Status | Completed |
Enrollment | 135 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ahmed Noaman |
Bertrand P, Araníbar H, Castro E, Sánchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. — View 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. — View 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. — View 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. — View Citation
Vollsæter M, Røksund 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. — View Citation
Yurdakök 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of oxygen support & O2 concentration until Downes' score less than 4 | through study completion, about 1 year | ||
Secondary | Length of hospital stay until Downes' score less than 4 | through study completion, about 1 year | ||
Secondary | Type of respiratory support (oxygen delivery and oxygen concentration) | within 12 hours after intervention | ||
Secondary | Effect of intervention on blood sugar (mg/dl) | within 12 hours after intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01206946 -
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
|
Phase 2 | |
Completed |
NCT01310153 -
Effect of Supine or Prone Position After Caesarean Birth
|
N/A | |
Active, not recruiting |
NCT04780412 -
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
|
Phase 3 | |
Completed |
NCT01517958 -
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
|
N/A | |
Withdrawn |
NCT03499418 -
Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates
|
||
Completed |
NCT01859533 -
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
|
Phase 2 | |
Completed |
NCT03208894 -
Role of Salbutamol and Furosemide in TTN
|
Phase 3 | |
Recruiting |
NCT01858129 -
Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn
|
Phase 2 | |
Completed |
NCT01772381 -
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
|
N/A | |
Completed |
NCT01225029 -
Fluid Management in Transient Tachypnea of the Newborn
|
N/A | |
Recruiting |
NCT01270581 -
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
|
N/A | |
Recruiting |
NCT06278415 -
Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery
|
N/A | |
Not yet recruiting |
NCT06200519 -
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
|
||
Completed |
NCT02965365 -
PATET Ratio to Rule Out Transient Tachypnea of the Newborn
|
N/A | |
Recruiting |
NCT05538780 -
Diagnosis of Transient Tachypnea of Newborn
|
||
Completed |
NCT04722016 -
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE
|
||
Recruiting |
NCT06270823 -
Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT03006354 -
nHFOV Versus nCPAP in Transient Tachypnea of the Newborn
|
N/A | |
Recruiting |
NCT03346343 -
Pulmonary Function Using Non-invasive Forced Oscillometry
|
N/A | |
Completed |
NCT03165305 -
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
|
N/A |