Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
Primary Purpose
Transient Tachypnea of the Newborn
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Neopuff
Sponsored by
About this trial
This is an interventional prevention trial for Transient Tachypnea of the Newborn
Eligibility Criteria
Inclusion Criteria:
- Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
- Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
- Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Exclusion Criteria:
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
Presence of any other cause of respiratory distress, eg.
- congenital malformations affecting the cardiorespiratory system ,
- chromosomal aberrations,
- depression at birth (Apgar score at 5 minutes of < 7 or umbilical artery pH of < 7.10),
- fetal hydrops,
- persistent pulmonary hypertension,
- and meconium aspiration syndrome.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neopuff group
Control group
Arm Description
includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).
Outcomes
Primary Outcome Measures
Need for admissions to NICU secondary to TTN
Secondary Outcome Measures
Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].
Duration of tachypnea.
Duration and type of oxygen therapy.
Antibiotic treatment.
Incidence of pulmonary air leaks
Length of hospital (NICU) stay
Death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01859533
Brief Title
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
Official Title
Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
Detailed Description
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neopuff group
Arm Type
Experimental
Arm Description
includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).
Intervention Type
Device
Intervention Name(s)
Neopuff
Other Intervention Name(s)
Early CPAP
Intervention Description
Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).
Primary Outcome Measure Information:
Title
Need for admissions to NICU secondary to TTN
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].
Time Frame
24 hours
Title
Duration of tachypnea.
Time Frame
until discharge
Title
Duration and type of oxygen therapy.
Time Frame
ntil discharge
Title
Antibiotic treatment.
Time Frame
until discharge
Title
Incidence of pulmonary air leaks
Time Frame
ntil discharge
Title
Length of hospital (NICU) stay
Time Frame
until discharge
Title
Death
Time Frame
until discharge
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Exclusion Criteria:
Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
Presence of any other cause of respiratory distress, eg.
congenital malformations affecting the cardiorespiratory system ,
chromosomal aberrations,
depression at birth (Apgar score at 5 minutes of < 7 or umbilical artery pH of < 7.10),
fetal hydrops,
persistent pulmonary hypertension,
and meconium aspiration syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania A. El-Farrash, MD, PhD
Organizational Affiliation
Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amani O. Mahmoud, MD
Organizational Affiliation
Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Enas H. Abdul-Hady, M.B.B.Ch
Organizational Affiliation
Ministry of Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
We'll reach out to this number within 24 hrs