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Sustained Lung Inflation With CPAP in Preterm Neonates (SI-CPAP) (SI-CPAP)

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ClinicalTrials.gov Identifier: NCT03916523
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada Ibrahim Gad, Ain Shams University

Brief Summary:

Neonatal respiratory distress syndrome (RDS) is the most common cause of respiratory failure in the first few days in life. It is characterized by the tendency of alveoli and terminal bronchioles to collapse due to the lack of surfactant. RDS is inversely related to gestational age and remains a dominant clinical problem encountered among preterm infants.

The reduction in tidal volume secondary to alveolar collapse may result in alveolar derecruitment, cyclic opening and closing of atelectatic alveoli and distal small airways leading to inflammation and lung injury). On the other hand, the use of high positive end expiratory pressure (PEEP) may be associated with excessive lung parenchyma strain and unfavorable hemodynamic effects. Therefore, lung recruitment maneuvers have been proposed and used to open collapsed lung while managing with low pressure PEEP. However, the best recruitment maneuver technique is currently unknown.

Proinflammatory cytokines are synthesized by alveolar macrophages, type II pneumocytes and other local pulmonary cells causing inflammation that starts a cascade leading to lung injury. Nevertheless, they are released systemically and can lead to injury of other organs.

This study aims to measure inflammatory cytokines in the serum of premature infants who receive and do not receive sustained lung inflation. The study hypothesis is that, in premature infants supported with CPAP, the use of sustained inflation is associated with decreased inflammatory biomarkers and improved respiratory outcomes.

The study includes infants with gestational age of 28-24 weeks during the first 6 hours of life who will be randomly assigned to either receive (or do not receive) sustained inflations. Serum concentrations of cytokines (IL-6, IL-8, IL-1β and TNF-α) will be measured at enrollment and at 96 hours. The primary outcome of this study will be the change in serum cytokine concentrations after intervention in both groups. Clinical respiratory outcomes will be monitored.


Condition or disease Intervention/treatment Phase
RDS of Prematurity Procedure: Sustained lung inflation Procedure: Continuous positive airway pressure (CPAP) Procedure: Mechanical ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: All laboratory testing will be performed by investigators who are not aware of group assignment.
Primary Purpose: Treatment
Official Title: Effect of Sustained Lung Inflation During CPAP in Preterm Neonates With Respiratory Distress Syndrome
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : March 15, 2016


Arm Intervention/treatment
Experimental: Group A
Infants in the group receive CPAP for respiratory support in the delivery room. In addition, they receive a total of 15 sustained lung inflations in the first 96 hours of life; 6 in the first day, 3 in the second day, 3 in the third day and 3 in the forth day of life.
Procedure: Sustained lung inflation

Preterm infants will receive a total of 15 sustained lung inflations during the first 4 days of life as follows:

  1. On day 1 of life (a total of 6 sustained lung inflations, 20 cmH2O for 21 seconds each) once at enrollment and then once every 4 hours
  2. On day 2 of life (a total of 3 sustained lung inflations, 15 cmH2O for 21 seconds each) once every 8 hours.
  3. On day 3 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours.
  4. On day 4 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours.

Experimental: Group B
Infants in the group receive CPAP for respiratory support in the delivery room. No sustained lung inflation will be applied.
Procedure: Continuous positive airway pressure (CPAP)
Preterm infants will receive CPAP for respiratory support.
Other Name: CPAP

Active Comparator: Group C
Infants in this group are intubated in the delivery room and supported with mechanical ventilation.
Procedure: Mechanical ventilation
Preterm infants in this group will receive mechanical ventilation for respiratory support




Primary Outcome Measures :
  1. Serum concentration of cytokines [ Time Frame: At 96 hours of life ]
    IL-6, IL-8, IL-1β, - TNF-α and elastase will be measured in all subjects in group, group B, and group C.


Secondary Outcome Measures :
  1. Oxygen requirement [ Time Frame: At 96 hours of life ]
    Fraction of inspired oxygen (FiO2) while on CPAP



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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age between 28 weeks (and 0 days) and 34 weeks (and 6 days)
  2. Postnatal age <6 hours
  3. Respiratory distress syndrome diagnosed by both clinical findings of subcostal retractions, tachypnea (>70 breaths/min), the need for respiratory support to maintain oxygen saturation > 87% and X-ray findings of RDS
  4. Application of early CPAP <6 hours of age
  5. Oxygen requirement (FiO2 >30% to maintain preductal saturation 87% - 93%)

Exclusion Criteria:

  • Before enrollment: infants will not be considered in the study if any of the following conditions exists: major congenital anomalies, severe hemodynamic instability indicative of early septicemia, use of inotropes, severe metabolic acidemia with base deficit >12 mEq/dl, frequent apnea / bradycardia (6 episodes per day with HR <100 or 2 episodes per day with HR<60 requiring bag-and-mask ventilation), maternal chorioamnionitis (fever >38 degree Celsius with abdominal tenderness) and PPROM >18 hours, and perinatal hypoxia (Apgar score < 6 at 5 minutes)
  • After enrollment: infants will be eliminated from the study if the initial blood culture on admission is positive.
Publications:
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Responsible Party: Ghada Ibrahim Gad, Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT03916523    
Other Study ID Numbers: 02072012
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Ibrahim Gad, Ain Shams University:
Sustained lung inflation
Lung injury
Delivery room management
CPAP
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications