Transient Tachypnea of the NewbornPhase 2NCT01859533
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
A Phase 2 study testing Neopuff in people with Transient Tachypnea of the Newborn, run by Ain Shams University.
Trial summary
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- Neopuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to May 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 Up to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
- Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
- Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Who cannot join
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
- Presence of any other cause of respiratory distress, eg.
- congenital malformations affecting the cardiorespiratory system ,
- chromosomal aberrations,
- depression at birth (Apgar score at 5 minutes of < 7 or umbilical artery pH of < 7.10),
- fetal hydrops,
- persistent pulmonary hypertension,
- and meconium aspiration syndrome.
About this study
Official title: Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
Read the detailed description
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- Neopuff
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeopuffDevice
Also called Early CPAP
- Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
- Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).
| Study group | Role | What they receive |
|---|---|---|
| Neopuff group | Experimental | includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand). Receives: Device: Neopuff |
| Control group | No intervention | includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for admissions to NICU secondary to TTN
Measured: 24 hours
Secondary outcomes (7)
Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].
Measured: 24 hours
Duration of tachypnea.
Measured: until discharge
Duration and type of oxygen therapy.
Measured: ntil discharge
Antibiotic treatment.
Measured: until discharge
Incidence of pulmonary air leaks
Measured: ntil discharge
Length of hospital (NICU) stay
Measured: until discharge
Death
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea of the 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- Rania A. El-Farrash, MD, PhD, Principal investigator, Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, EgyptAmani O. Mahmoud, MD, Study chair, Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, EgyptEnas H. Abdul-Hady, M.B.B.Ch, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859533
- Sponsor's protocol ID
- Ain Shams Uni
- Status last verified
- May 2013
- First submitted
- 16 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01859533
- Acronym / sponsor ID
- Ain Shams Uni
- Conditions
- Transient Tachypnea of the Newborn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 May 2013 (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.
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
Detailed description
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neopuff group | Experimental | Device: Neopuffincludes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand). |
| Control group | No intervention | –includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010). |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
- Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
- Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Key exclusion criteria (8 listed)
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
- Presence of any other cause of respiratory distress, eg.
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 |
|---|---|---|
| NeopuffAlso: Early CPAP* Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand). * Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010). | Device | Neopuff group |
Primary outcome
Need for admissions to NICU secondary to TTN
Time frame: 24 hours
7 secondary outcomes
Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].
Time frame: 24 hours
Duration of tachypnea.
Time frame: until discharge
Duration and type of oxygen therapy.
Time frame: ntil discharge
Antibiotic treatment.
Time frame: until discharge
Incidence of pulmonary air leaks
Time frame: ntil discharge
Length of hospital (NICU) stay
Time frame: until discharge
Death
Time frame: until discharge
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 22 May 2013.
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The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
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the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
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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.
Rania A. El-Farrash, MD, PhD principal investigator
Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Amani O. Mahmoud, MD study chair
Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Enas H. Abdul-Hady, M.B.B.Ch principal investigator
Ministry of Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neopuff in people with Transient Tachypnea of the Newborn, 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 3 inclusion and 8 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 22 May 2013. 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.
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?
Need for admissions to NICU secondary to TTN (time frame: 24 hours). 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 22 May 2013.