Respiratory Distress Syndrome, NewbornPhase 2NCT01255826
Ventilatory Management of the Preterm Neonate in the Delivery Room
A Phase 2 study testing Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP and Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag. in people with Respiratory Distress Syndrome, Newborn, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with… Read more about this study
- Who is it for?
- Ages 27 to 33 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP and Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- 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 27 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants (gestational age < 34 weeks)
Who cannot join
- 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).
- 2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.
- 3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilatory Management of the Preterm Neonate in the Delivery Room.
The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
Read the detailed description
Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.
Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.
Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.
Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.
Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.
Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth.
This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP, Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.
- Keywords
- Preterm, Neonates, Delivery room, Resuscitation, Ventilation, Neopuff, CPAP
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAPProcedure or surgery
After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is < 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.
Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.Procedure or surgery
After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.
| Study group | Role | What they receive |
|---|---|---|
| Sustained lung inflation followed by CPAP | Active comparator | Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel, Auckland, New Zealand).
This will be followed by early CPAP. Receives: Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP |
| Conventional self inflating bag and mask ventilation | Active comparator | Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir. Receives: Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
Measured: 2 minutes
Need for mechanical ventilation for neonates on nCPAP
Measured: 28 days
Secondary outcomes (10)
Occurrence and duration of oxygen therapy.
Measured: 28 days
Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.
Measured: 28 days
Pulmonary air leaks
Measured: 28 days
Patent ductus arteriosus (PDA).
Measured: 7 days
Necrotizing enterocolitis (NEC).
Measured: 28 days
Intraventricular hemorrhage (IVH).
Measured: 28 days
Neonatal sepsis.
Measured: 28 days
Length of NICU stay.
Measured: 28 days
Delivery room death or death during admission.
Measured: 28 days
Inflammatory mediators before and after resuscitation
Serum Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α)will be measured both initial cord blood before any resuscitation is done and a second time two hours after resuscitation.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Mohamed Shinkar, Ain Shams University
- Investigators
- Mohamed Sami El Shimi, MD, Principal investigator, Ain Shams UniversityHesham Abdel Samie Awad, MD, Principal investigator, Ain Shams UniversityTarek Mohey El Gammacy, MD, Principal investigator, Ain Shams UniversityOla Galal Badr El Deen, MD, Principal investigator, Ain Shams UniversityDina Mohamed Mohamed Shinkar, MSc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255826
- Sponsor's protocol ID
- Dina Shinkar MD protocol
- Other IDs
- Sustianed inflation trial
- Status last verified
- Aug 2017
- First submitted
- 7 Dec 2010
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Management of the Preterm Neonate in the Delivery Room.
- ClinicalTrials.gov ID
- NCT01255826
- Acronym / sponsor ID
- Dina Shinkar MD protocol
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- Preterm, Neonates, Delivery room, Resuscitation, Ventilation, Neopuff, CPAP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Dec 2010 (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 purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
Detailed description
Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.
Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.
Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.
Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.
Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.
Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth.
This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained lung inflation followed by CPAP | Active comparator | Procedure: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAPSustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel, Auckland, New Zealand). This will be followed by early CPAP. |
| Conventional self inflating bag and mask ventilation | Active comparator | Procedure: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir. |
Who may qualify
- Ages
- 27 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants (gestational age < 34 weeks)
Key exclusion criteria (3 listed)
- 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).
- 2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.
- 3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.
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 |
|---|---|---|
| Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAPAfter oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is < 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O. | Procedure or surgery | Sustained lung inflation followed by CPAP |
| Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir. | Procedure or surgery | Conventional self inflating bag and mask ventilation |
Primary outcome
Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
Time frame: 2 minutes
Need for mechanical ventilation for neonates on nCPAP
Time frame: 28 days
10 secondary outcomes
Occurrence and duration of oxygen therapy.
Time frame: 28 days
Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.
Time frame: 28 days
Pulmonary air leaks
Time frame: 28 days
Patent ductus arteriosus (PDA).
Time frame: 7 days
Necrotizing enterocolitis (NEC).
Time frame: 28 days
Intraventricular hemorrhage (IVH).
Time frame: 28 days
Neonatal sepsis.
Time frame: 28 days
Length of NICU stay.
Time frame: 28 days
Delivery room death or death during admission.
Time frame: 28 days
Inflammatory mediators before and after resuscitation
Time frame: 2 hours
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 31 Aug 2017.
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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.
Mohamed Sami El Shimi, MD principal investigator
Ain Shams University
Hesham Abdel Samie Awad, MD principal investigator
Ain Shams University
Tarek Mohey El Gammacy, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP and Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag. in people with Respiratory Distress Syndrome, Newborn, run by Ain Shams University 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 3 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 31 Aug 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room. (time frame: 2 minutes). The study lists 2 primary outcomes in all. 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 31 Aug 2017.