Respiratory Distress SyndromePhase 1NCT02846597
Proper Pressure and Duration of Sustained Lung Inflation in Preterm Infants
A Phase 1 study testing Sustained lung inflation in preterms (SLI). in people with Respiratory Distress Syndrome, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Sustained lung inflation in preterms (SLI).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Oct 2016
- Phase
- Phase 1
- 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 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with gestational age ≤ 32 weeks' gestation, presented with respiratory distress syndrome at birth
Who cannot join
- - Preterm infants with no manifestations of respiratory distress syndrome at birth.
- - Presence of major congenital malformation (dysmorphic features or anomalies incompatible with life) .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Children Hospital
Al Mansurah, El Dakahlya, 35111
About this study
Official title: Sustained Lung Inflation at Birth for Preterm Infants at Risk of Respiratory Distress Syndrome: the Proper Pressure and Duration: Prospective Randomized Study
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.
Read the 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:
- 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
- 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
- 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.
- 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.
- 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
- All infants will receive initial care including providing warmth, clearing the airway, and drying and stimulating the infant.
- After the initial steps, pulse oximetry will be initiated to determine oxygen saturation and to guide the required FIO2.
- Infants in the intervention groups will receive a single single maneuver of sustained lung inflation with the first breath according to the study group.
- 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.
- 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.
- Oxygen therapy will be titrated to keep a pre-ductal saturation between 90-95%.
- Endotracheal intubation will be provided if positive pressure ventilation is ineffective, prolonged apnea, or chest compression is required.
- Chest compression will be required if the infant's heart rate remains <60 bpm despite adequate ventilation for 30 seconds.
- 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.
- 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).
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Sustained lung inflation in preterms (SLI).
- Keywords
- Respiratory distress syndrome, Sustained lung inflation, Delivery room
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained lung inflation in preterms (SLI).Procedure or surgery
Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Infants in this group will not receive sustained lung inflation in the delivery room and will be put immediately on CPAP at a pressure of 5 cm H2O. |
| High pressure for long duration | Active comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. Receives: Procedure: Sustained lung inflation in preterms (SLI). |
| High pressure for short duration | Active comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. Receives: Procedure: Sustained lung inflation in preterms (SLI). |
| Low pressure for long duration | Active comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. Receives: Procedure: Sustained lung inflation in preterms (SLI). |
| Low pressure for short duration | Active comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. Receives: Procedure: Sustained lung inflation in preterms (SLI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for endotracheal intubation in the delivery room
Measured: One hour
Secondary outcomes (9)
The need for mechanical ventilation
Measured: 72 hours
Need of surfactant
Measured: 72 hours
Neonatal mortality
Death before hospital discharge
Measured: 90 days
Broncho Pulmonary Dysplasia ( BPD )
Requirement for oxygen therapy more than 30% by 36 weeks corrected gestational age
Measured: 90 days
Intra-Ventricular Hemorrhage ( IVH )
Measured: 14 days
Retinopathy of Prematurity ( ROP )
Measured: 50 days
Necrotizing Entero Colitis ( NEC )
Measured: 40 days
Length of neonatal intensive care ( NICU ) and hospital stay
Measured: 90 days
Air-leak syndrome
Development of pneumothorax or pneumomediastinum
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMar 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Nasef, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846597
- Sponsor's protocol ID
- NICU MUCH 2016
- Status last verified
- Apr 2018
- First submitted
- 22 Jul 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Lung Inflation at Birth for Preterm Infants at Risk of Respiratory Distress Syndrome: the Proper Pressure and Duration: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02846597
- Acronym / sponsor ID
- NICU MUCH 2016
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory distress syndrome, Sustained lung inflation, Delivery room
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
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:
- 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
- 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
- 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.
- 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.
- 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
- All infants will receive initial care including providing warmth, clearing the airway, and drying and stimulating the infant.
- After the initial steps, pulse oximetry will be initiated to determine oxygen saturation and to guide the required FIO2.
- Infants in the intervention groups will receive a single single maneuver of sustained lung inflation with the first breath according to the study group.
- 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.
- 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.
- Oxygen therapy will be titrated to keep a pre-ductal saturation between 90-95%.
- Endotracheal intubation will be provided if positive pressure ventilation is ineffective, prolonged apnea, or chest compression is required.
- Chest compression will be required if the infant's heart rate remains <60 bpm despite adequate ventilation for 30 seconds.
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Infants in this group will not receive sustained lung inflation in the delivery room and will be put immediately on CPAP at a pressure of 5 cm H2O. |
| High pressure for long duration | Active comparator | Procedure: Sustained lung inflation in preterms (SLI).Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
| High pressure for short duration | Active comparator | Procedure: Sustained lung inflation in preterms (SLI).Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
| Low pressure for long duration | Active comparator | Procedure: Sustained lung inflation in preterms (SLI).Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
| Low pressure for short duration | Active comparator | Procedure: Sustained lung inflation in preterms (SLI).Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants with gestational age ≤ 32 weeks' gestation, presented with respiratory distress syndrome at birth
Key exclusion criteria (2 listed)
- - Preterm infants with no manifestations of respiratory distress syndrome at birth.
- - Presence of major congenital malformation (dysmorphic features or anomalies incompatible with life) .
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 in preterms (SLI).Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time | Procedure or surgery | High pressure for long duration, High pressure for short duration, Low pressure for long duration, Low pressure for short duration |
Primary outcome
The need for endotracheal intubation in the delivery room
Time frame: One hour
9 secondary outcomes
The need for mechanical ventilation
Time frame: 72 hours
Need of surfactant
Time frame: 72 hours
Neonatal mortality
Time frame: 90 days
Broncho Pulmonary Dysplasia ( BPD )
Time frame: 90 days
Intra-Ventricular Hemorrhage ( IVH )
Time frame: 14 days
Retinopathy of Prematurity ( ROP )
Time frame: 50 days
Necrotizing Entero Colitis ( NEC )
Time frame: 40 days
Length of neonatal intensive care ( NICU ) and hospital stay
Time frame: 90 days
Air-leak syndrome
Time frame: 14 days
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 3 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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 Phase 1 study testing Sustained lung inflation in preterms (SLI). in people with Respiratory Distress Syndrome, run by Mansoura University Children 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 1 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 3 Apr 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The need for endotracheal intubation in the delivery room (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2018.