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

NCT03916523 | Completed DMC

• 1 other identifier: 02072012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

RDS of Prematurity

Keywords

Sustained lung inflation; Lung injury; Delivery room management; CPAP

Outcome Measures

Primary Outcomes (1)

• Serum concentration of cytokines

  IL-6, IL-8, IL-1β, - TNF-α and elastase will be measured in all subjects in group, group B, and group C.

  At 96 hours of life

Secondary Outcomes (1)

• Oxygen requirement

  At 96 hours of life

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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)

Group C

ACTIVE COMPARATOR

Infants in this group are intubated in the delivery room and supported with mechanical ventilation.

Procedure: Mechanical ventilation

Interventions

Sustained lung inflation PROCEDURE

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.

Group A

Continuous positive airway pressure (CPAP) PROCEDURE

Preterm infants will receive CPAP for respiratory support.

Also known as: CPAP

Group B

Mechanical ventilation PROCEDURE

Preterm infants in this group will receive mechanical ventilation for respiratory support

Group C

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age between 28 weeks (and 0 days) and 34 weeks (and 6 days)
• Postnatal age \<6 hours
• 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
• Application of early CPAP \<6 hours of age
• Oxygen requirement (FiO2 \>30% to maintain preductal saturation 87% - 93%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• Abdel-Hady H, Shouman B, Aly H. Early weaning from CPAP to high flow nasal cannula in preterm infants is associated with prolonged oxygen requirement: a randomized controlled trial. Early Hum Dev. 2011 Mar;87(3):205-8. doi: 10.1016/j.earlhumdev.2010.12.010. Epub 2011 Jan 26.

  PMID: 21276671 BACKGROUND

• Aly H. Ventilation without tracheal intubation. Pediatrics. 2009 Aug;124(2):786-9. doi: 10.1542/peds.2009-0256. Epub 2009 Jul 27. No abstract available.

  PMID: 19651592 BACKGROUND

• Attar MA, Donn SM. Mechanisms of ventilator-induced lung injury in premature infants. Semin Neonatol. 2002 Oct;7(5):353-60. doi: 10.1053/siny.2002.0129.

  PMID: 12464497 BACKGROUND

• Lista G, Fontana P, Castoldi F, Cavigioli F, Dani C. Does sustained lung inflation at birth improve outcome of preterm infants at risk for respiratory distress syndrome? Neonatology. 2011;99(1):45-50. doi: 10.1159/000298312. Epub 2010 Jul 9.

  PMID: 20616570 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Lung Injury

Interventions

Continuous Positive Airway Pressure; Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Airway Management; Therapeutics; Respiratory Therapy; Resuscitation; Emergency Treatment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All laboratory testing will be performed by investigators who are not aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2013
• Primary Completion: March 15, 2016
• Study Completion: March 15, 2016
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share