Proper Pressure and Duration of Sustained Lung Inflation in Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The appropriate pressure and duration needed for sustained lung inflation in preterm infants
      at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating
      two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds,
      during the application of sustained lung inflation in the resuscitation of preterm infants
      with respiratory distress in the delivery room.
    

Detailed description: 
      This study will be a randomized prospective pilot study in Mansoura University Hospital then
      the cases were followed at Neonatal Intensive Care Unit in Mansoura University Children
      Hospital, Mansoura, Egypt.

      Preterm infants born equal to or less than 32 weeks gestation with respiratory distress
      syndrome will be included in the study.

      We aim to study the proper pressure and duration of sustained lung inflation in the delivery
      room.

      Preterm infants will be divided into 5 groups:

        1. Group 1 (Control group). In this group preterm infants will not be treated with
           sustained lung inflation and in stead will receive regular respiratory care

        2. Group 2 (High pressure for long duration group). Preterm infants in this group will be
           treated with sustained lung inflation at pressure of 20 cm H2O for 20 seconds

        3. Group 3 (High pressure for short duration group). Preterm infants in this group will be
           treated with sustained lung inflation at pressure of 20 cm H2O for 10 seconds.

        4. Group 4 (Low pressure for long duration group). Preterm infants in this group will be
           treated with sustained lung inflation at pressure of 15 cm H2O for 20 seconds.

        5. Group 5 (Low pressure for short duration group). Preterm infants in this group will be
           treated with sustained lung inflation at pressure of 15 cm H2O for 10 seconds

      Sustained lung inflation will be delivered using the T - piece ventilator (Neopuff infant
      resuscitator; Fisher & Paykel, Auckland, New Zealand ).

      All preterm infants with respiratory distress will follow the following steps for neonatal
      resuscitation

        1. All infants will receive initial care including providing warmth, clearing the airway,
           and drying and stimulating the infant.

        2. After the initial steps, pulse oximetry will be initiated to determine oxygen saturation
           and to guide the required FIO2.

        3. Infants in the intervention groups will receive a single single maneuver of sustained
           lung inflation with the first breath according to the study group.

        4. Continuous positive airway pressure at a pressure of 5 cm H2O and FIO2 of 30% will be
           delivered to infants in the control group immediately after initial steps of
           resuscitation and to all infants in the intervention groups after the single maneuver of
           sustained lung inflation.

        5. Positive pressure ventilation will be provided uring the T-piece resuscitator if the
           infant has an inadequate respiratory effort or a heart rate <100 beats per minute at a
           rate of 40 to 60 times per minute for 30 seconds, after which the heart rate is
           measured.

        6. Oxygen therapy will be titrated to keep a pre-ductal saturation between 90-95%.

        7. Endotracheal intubation will be provided if positive pressure ventilation is
           ineffective, prolonged apnea, or chest compression is required.

        8. Chest compression will be required if the infant's heart rate remains <60 bpm despite
           adequate ventilation for 30 seconds.

        9. Surfactant will be administered to preterm infants requiring a fraction of inspired
           oxygen of 40 percent or higher to maintain oxygen saturation above 90 percent or remain
           apneic.

       10. Mechanical ventilation will be initiated for preterm infants with respiratory acidosis
           documented by an arterial pH <7.2 and PaCO2 >60 to 65 mmHg, hypoxia documented by an
           arterial PaO2 <50 mmHg despite FiO2 exceeds 40 percent on nasal continuous positive
           airway pressure, or severe apnea.

      The primary outcome of the study will be the need for endotracheal intubation in the delivery
      room.

      Secondary outcomes include the need for surfactant therapy, the need for endotracheal
      intubation and mechanical ventilation within 72 hours of birth, the duration of mechanical
      ventilation and oxygen support, development of air leak syndromes, length of hospital stay,
      bronchopulmonary dysplasia, necrotising enterocolitis, intraventricular haemorrhage,
      retinopathy of prematurity, and neonatal mortality before hospital discharge,.

      Broncho alveolar lavage will be performed to endotracheally intubated infants enrolled in
      this study to measure the level of IL-10 as a lung inflammatory marker immediately after
      birth (basal) then 12 hours after birth (follow up).
    

Intervention name(s): Sustained lung inflation in preterms (SLI).
Intervention type(s): Procedure
Intervention description(s): Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory distress syndrome; Sustained lung inflation; Delivery room