Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
This study is currently recruiting participants.
Verified December 2011 by Zekai Tahir Burak Maternity and Teaching Hospital
Sponsor:
Zekai Tahir Burak Maternity and Teaching Hospital
Information provided by (Responsible Party):
Gamze Demirel, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01499238
First received: December 14, 2011
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.
| Condition | Intervention | Phase |
|---|---|---|
|
Transient Tachypnea of Newborn |
Device: Nasal SIMV Device: nasal CPAP |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn |
Resource links provided by NLM:
Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:
Primary Outcome Measures:
- efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Complications of respiratory support, respiratory insufficiency [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]pneumothorax
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: nasal SIMV
rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40%
|
Device: Nasal SIMV
rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%
Other Name: nasal SIMV, SLE 5000
|
|
Active Comparator: nasal CPAP
PEEP: 4-6 mmHg, Fio2: 40%
|
Device: nasal CPAP
PEEP: 4-6 mmHg, FİO2: 40%
Other Name: NASAL CPAP, SLE 5000
|
Detailed Description:
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- >35 gestational week
- wetlung
Exclusion Criteria:
- major congenital anomalies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499238
Contacts
| Contact: Gamze Demirel, MD | kgamze@hotmail.com |
Locations
| Turkey | |
| Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology | Recruiting |
| Ankara, Turkey | |
| Contact: Gamze Demirel, MD kgamze@hotmail.com | |
| Principal Investigator: Gamze Demirel, MD | |
| Zekai Tahir Burak Maternity Teaching Hospital | Recruiting |
| Ankara, Turkey | |
| Contact: Gamze Demirel, MD kgamze@hotmail.com | |
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
| Principal Investigator: | Gamze Demirel, MD | Zekai Tahir Burak Maternity Teaching Hospital |
More Information
No publications provided
| Responsible Party: | Gamze Demirel, Zekai Tahir Burak Maternity Teaching Hospital, Zekai Tahir Burak Maternity and Teaching Hospital |
| ClinicalTrials.gov Identifier: | NCT01499238 History of Changes |
| Other Study ID Numbers: | 4 |
| Study First Received: | December 14, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
|
Efficacy safety nasal SIMV nasal CPAP infants who are >35 gestational week with wet lung |
ClinicalTrials.gov processed this record on May 19, 2013