Ventilatory Management of the Preterm Neonate in the Delivery Room

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Mohamed Shinkar, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01255826
First received: December 7, 2010
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.


Condition Intervention Phase
Respiratory Distress Syndrome.
Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP
Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ventilatory Management of the Preterm Neonate in the Delivery Room.

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room. [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
  • Need for mechanical ventilation for neonates on nCPAP [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence and duration of oxygen therapy. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Pulmonary air leaks [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Patent ductus arteriosus (PDA). [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Necrotizing enterocolitis (NEC). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Intraventricular hemorrhage (IVH). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Length of NICU stay. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Delivery room death or death during admission. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Inflammatory mediators before and after resuscitation [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    Serum Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α)will be measured both initial cord blood before any resuscitation is done and a second time two hours after resuscitation.


Enrollment: 112
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sustained lung inflation followed by CPAP

Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel, Auckland, New Zealand).

This will be followed by early CPAP.

Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP
After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is < 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.
Active Comparator: Conventional self inflating bag and mask ventilation
Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.
Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.

Detailed Description:

Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.

Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.

Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.

Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.

Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.

Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth.

This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.

  Eligibility

Ages Eligible for Study:   27 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants (gestational age < 34 weeks)

Exclusion Criteria:

  • 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).

    2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.

    3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255826

Locations
Egypt
Gynecology and Obstetrics hospital, Ain-Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Mohamed Sami El Shimi, MD Ain Shams University
Principal Investigator: Hesham Abdel Samie Awad, MD Ain Shams University
Principal Investigator: Tarek Mohey El Gammacy, MD Ain Shams University
Principal Investigator: Ola Galal Badr El Deen, MD Ain Shams University
Principal Investigator: Dina Mohamed Mohamed Shinkar, MSc Ain Shams University
  More Information

No publications provided

Responsible Party: Dina Mohamed Mohamed Shinkar, MD, Ain Shams University
ClinicalTrials.gov Identifier: NCT01255826     History of Changes
Other Study ID Numbers: Dina Shinkar MD protocol, Sustianed inflation trial
Study First Received: December 7, 2010
Last Updated: September 12, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
Preterm
Neonates
Delivery room
Resuscitation
Ventilation
Neopuff
CPAP

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 30, 2014