Transient TachypneaNCT01082900
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
A study testing Prophylactic CPAP Administration in people with Transient Tachypnea, run by New York Hospital Queens at 1 site in United States.
Trial summary
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Read more about this study
- Who is it for?
- Ages 2 to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Transient Tachypnea
- What is being tested?
- Prophylactic CPAP Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 2013
- 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 2 to 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
- Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)
Who cannot join
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
- Need for use of PPV for perinatal depression or other indications
- Presence of any of the following
- congenital malformations (diagnosed prenatally)
- chromosomal anomalies (diagnosed prenatally)
- congenital heart disease diagnosed by fetal echocardiography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic CPAP/PEEP in Delivery Room (DR) Resuscitation, Effects on Natriuretic Peptide in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.
- Conditions
- Transient Tachypnea
- Being tested
- Prophylactic CPAP Administration
- Keywords
- Transient Tachypnea of the Newborn, Elective Cesarean section, Late preterm, CPAP, Delivery Room
- 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.
Prophylactic CPAP AdministrationOther
EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)
CONTROL GROUP: Provision of standard care in the Delivery Room
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic CPAP intervention | Experimental | Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff) Receives: Other: Prophylactic CPAP Administration |
| No Intervention | Active comparator | Provision of standard care in the Delivery Room Receives: Other: Prophylactic CPAP Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of incidence of TTN
Measured: 24 hours
Need for admissions to NICU secondary to TTN
Measured: 24 hours
Secondary outcomes (1)
levels of plasma brain natriuretic peptide compared
- Duration of tachypnea
- Duration of oxygen therapy
- Length of hospital (NICU) stay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient TachypneaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Hospital Queens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pinchi srinivasan, New York Hospital Queens
- Investigators
- Pinchi Srinivasan, MD, Principal investigator, New York Hospital Queens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082900
- Sponsor's protocol ID
- 5720108
- Status last verified
- Oct 2015
- First submitted
- 8 Mar 2010
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic CPAP/PEEP in Delivery Room (DR) Resuscitation, Effects on Natriuretic Peptide in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01082900
- Acronym / sponsor ID
- 5720108
- Conditions
- Transient Tachypnea
- Keywords
- Transient Tachypnea of the Newborn, Elective Cesarean section, Late preterm, CPAP, Delivery Room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- New York Hospital QueensUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Mar 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.
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic CPAP intervention | Experimental | Other: Prophylactic CPAP AdministrationBabies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff) |
| No Intervention | Active comparator | Other: Prophylactic CPAP AdministrationProvision of standard care in the Delivery Room |
Who may qualify
- Ages
- 2 to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
- Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)
Key exclusion criteria (6 listed)
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
- Need for use of PPV for perinatal depression or other indications
- Presence of any of the following
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 |
|---|---|---|
| Prophylactic CPAP AdministrationEXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff) CONTROL GROUP: Provision of standard care in the Delivery Room | Other | No Intervention, Prophylactic CPAP intervention |
Primary outcome
Measure of incidence of TTN
Time frame: 24 hours
Need for admissions to NICU secondary to TTN
Time frame: 24 hours
1 secondary outcome
levels of plasma brain natriuretic peptide compared
Time frame: 24 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 6 Oct 2015.
Related trials for Transient Tachypnea
RecruitingObservational study
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruitingObservational study
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
Diastolic Dysfunction, Neonatal Encephalopathy
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
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.
Pinchi Srinivasan, MD principal investigator
New York Hospital Queens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic CPAP Administration in people with Transient Tachypnea, run by New York Hospital Queens at 1 site in United States.
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 2 inclusion and 6 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 6 Oct 2015. 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 United States. 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?
Measure of incidence of TTN (time frame: 24 hours). 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 6 Oct 2015.