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NCT Number: NCT01255826

Ventilatory Management of the Preterm Neonate in the Delivery Room

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

27 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gynecology and Obstetrics hospital, Ain-Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP

Procedure

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.

Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.

Procedure

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.

Primary outcomes

  1. 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

  2. Need for mechanical ventilation for neonates on nCPAP

    Time frame: 28 days

Secondary outcomes

  1. Occurrence and duration of oxygen therapy.

    Time frame: 28 days

  2. Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.

    Time frame: 28 days

  3. Pulmonary air leaks

    Time frame: 28 days

  4. Patent ductus arteriosus (PDA).

    Time frame: 7 days

  5. Necrotizing enterocolitis (NEC).

    Time frame: 28 days

  6. Intraventricular hemorrhage (IVH).

    Time frame: 28 days

  7. Neonatal sepsis.

    Time frame: 28 days

  8. Length of NICU stay.

    Time frame: 28 days

  9. Delivery room death or death during admission.

    Time frame: 28 days

  10. Inflammatory mediators before and after resuscitation

    Time frame: 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ventilatory Management of the Preterm Neonate in the Delivery Room.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 8, 2010
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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