RDS of PrematuritySI-CPAPNCT03916523
Sustained Lung Inflation With CPAP in Preterm Neonates (SI-CPAP)
A study testing Sustained lung inflation, Continuous positive airway pressure (CPAP) and Mechanical ventilation in people with RDS of Prematurity, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- RDS of Prematurity
- What is being tested?
- Sustained lung inflation, Continuous positive airway pressure (CPAP) and Mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 15 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%)
Who cannot join
- 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.
About this study
Official title: Effect of Sustained Lung Inflation During CPAP in Preterm Neonates With Respiratory Distress Syndrome
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.
Read more
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
- Being tested
- Sustained lung inflation, Continuous positive airway pressure (CPAP), Mechanical ventilation
- Keywords
- Sustained lung inflation, Lung injury, Delivery room management, CPAP
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained lung inflationProcedure or surgery
Preterm infants will receive a total of 15 sustained lung inflations during the first 4 days of life as follows:
- 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
- On day 2 of life (a total of 3 sustained lung inflations, 15 cmH2O for 21 seconds each) once every 8 hours.
- On day 3 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours.
- On day 4 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours.
Continuous positive airway pressure (CPAP)Procedure or surgery
Also called CPAP
Preterm infants will receive CPAP for respiratory support.
Mechanical ventilationProcedure or surgery
Preterm infants in this group will receive mechanical ventilation for respiratory support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 96 hours of life
Secondary outcomes (1)
Oxygen requirement
Fraction of inspired oxygen (FiO2) while on CPAP
Measured: At 96 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2013
- Primary completion15 Mar 2016
- Study completion15 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RDS of PrematurityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ibrahim Gad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916523
- Sponsor's protocol ID
- 02072012
- Acronym
- SI-CPAP
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21276671Aly 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.
PubMed 19651592Attar 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.
PubMed 12464497Lista 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.
PubMed 20616570
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sustained Lung Inflation During CPAP in Preterm Neonates With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03916523
- Acronym / sponsor ID
- SI-CPAP / 02072012
- Conditions
- RDS of Prematurity
- Keywords
- Sustained lung inflation, Lung injury, Delivery room management, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Sustained lung inflationInfants 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. |
| Group B | Experimental | Procedure: Continuous positive airway pressure (CPAP)Infants in the group receive CPAP for respiratory support in the delivery room. No sustained lung inflation will be applied. |
| Group C | Active comparator | Procedure: Mechanical ventilationInfants in this group are intubated in the delivery room and supported with mechanical ventilation. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained lung inflationPreterm 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. | Procedure or surgery | Group A |
| Continuous positive airway pressure (CPAP)Also: CPAPPreterm infants will receive CPAP for respiratory support. | Procedure or surgery | Group B |
| Mechanical ventilationPreterm infants in this group will receive mechanical ventilation for respiratory support | Procedure or surgery | Group C |
Primary outcome
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.
1 secondary outcome
Oxygen requirement
Time frame: At 96 hours of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 21276671Abdel-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.
- Background: PubMed 19651592Aly 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.
- Background: PubMed 12464497Attar 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.
- Background: PubMed 20616570Lista 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained lung inflation, Continuous positive airway pressure (CPAP) and Mechanical ventilation in people with RDS of Prematurity, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of cytokines (time frame: At 96 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916523, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.