Preterm InfantNCT03518762
Sustained Lung Inflation in Preterm Infants
A study testing Sustained lung inflation (SLI) and Continuous positive airway pressure (CPAP) in people with Preterm Infant, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Sustained lung inflation (SLI) and Continuous positive airway pressure (CPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2014to 5 Sep 2017
- 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 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥ 27 weeks and ≤ 32 weeks
- Appropriate for gestational age
- Weight >800 grams
Who cannot join
- Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
- Fetal hydrops
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.
Read the detailed description
Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.
- Conditions
- Preterm Infant
- Being tested
- Sustained lung inflation (SLI), Continuous positive airway pressure (CPAP)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained lung inflation (SLI)Procedure or surgery
SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device
Continuous positive airway pressure (CPAP)Procedure or surgery
CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
| Study group | Role | What they receive |
|---|---|---|
| Sustained lung inflation | Experimental | Participants in this arm (n=80) received:
1. Sustained lung inflation (SLI) manoeuvre(s) was applied once or twice, based on the protocol algorithm.
Within the first 60 seconds of life, assessment for the need of advanced resuscitation (defined as the need for more than oxygen and tactile stimulation during resuscitation) was done;
* Infants who needed advanced resuscitation were considered to receive SLI as a rescue approach.
* Infants who needed only oxygen and tactile stimulation were considered to receive SLI as a prophylactic approach.
2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed. Receives: Procedure: Sustained lung inflation (SLI); Procedure: Continuous positive airway pressure (CPAP) |
| Control | Other | Participants in this arm (n=80) received:
1. Resuscitation according to the American academy of pediatrics guidelines.
2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed. Receives: Procedure: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for invasive mechanical ventilation or death
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
Measured: From birth up to 72 hours of life
Secondary outcomes (3)
Duration of invasive mechanical ventilation
The duration of intubation and invasive mechanical ventilation (in days)
Measured: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Pneumothorax
Pneumothorax, documented by radiological findings
Measured: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days
Measured: Assessed at 36 weeks postmenstrual age or discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start21 Dec 2014
- Primary completion18 Jan 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douaa El Saied El Sherbiny, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518762
- Sponsor's protocol ID
- 75381
- Status last verified
- Jun 2020
- First submitted
- 12 Apr 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.
PubMed 33254237
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03518762
- Acronym / sponsor ID
- 75381
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 21 Dec 2014 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 8 May 2018 (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.
This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.
Detailed description
Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained lung inflation | Experimental | Procedure: Sustained lung inflation (SLI), Procedure: Continuous positive airway pressure (CPAP)Participants in this arm (n=80) received: 1. Sustained lung inflation (SLI) manoeuvre(s) was applied once or twice, based on the protocol algorithm. Within the first 60 seconds of life, assessment for the need of advanced resuscitation (defined as the need for more than oxygen and tactile stimulation during resuscitation) was done; * Infants who needed advanced resuscitation were considered to receive SLI as a rescue approach. * Infants who needed only oxygen and tactile stimulation were considered to receive SLI as a prophylactic approach. 2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed. |
| Control | Other | Procedure: Continuous positive airway pressure (CPAP)Participants in this arm (n=80) received: 1. Resuscitation according to the American academy of pediatrics guidelines. 2. Then Continuous positive airway pressure (CPAP). Intermittent positive pressure ventilation (IPPV) was given through an ETT, if intubation was needed. |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age ≥ 27 weeks and ≤ 32 weeks
- Appropriate for gestational age
- Weight >800 grams
Key exclusion criteria (2 listed)
- Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
- Fetal hydrops
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 inflation (SLI)SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device | Procedure or surgery | Sustained lung inflation |
| Continuous positive airway pressure (CPAP)CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device. | Procedure or surgery | Control, Sustained lung inflation |
Primary outcome
Need for invasive mechanical ventilation or death
Time frame: From birth up to 72 hours of life
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
3 secondary outcomes
Duration of invasive mechanical ventilation
Time frame: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Pneumothorax
Time frame: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
Bronchopulmonary dysplasia
Time frame: Assessed at 36 weeks postmenstrual age or discharge, whichever came first
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 9 Jun 2020.
- Derived from this study: PubMed 33254237Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained lung inflation (SLI) and Continuous positive airway pressure (CPAP) in people with Preterm Infant, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Need for invasive mechanical ventilation or death (time frame: From birth up to 72 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 NCT03518762, which also lists 1 linked publication.
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 9 Jun 2020.