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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

About this trial

This is an interventional prevention trial for Transient Tachypnea of the Newborn

Eligibility Criteria

undefined - 2 Days (Child)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01859533

First Posted

May 16, 2013

Last Updated

May 20, 2013

Sponsor

Ain Shams University

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

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

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

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