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Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Gamze Demirel, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
Sponsor:
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
  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
Intervention Model: Parallel Assignment
Masking: None (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 Gamze Demirel, 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 ]

Secondary Outcome Measures:
  • Complications of respiratory support, respiratory insufficiency [ Time Frame: 3 months ]
    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   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >35 gestational week
  • wetlung

Exclusion Criteria:

  • major congenital anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Women's Health Research and Education Hospital
Investigators
Principal Investigator: Gamze Demirel, MD Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

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

Keywords provided by Gamze Demirel, Zekai Tahir Burak Maternity and Teaching Hospital:
Efficacy
safety
nasal SIMV
nasal CPAP
infants who are >35 gestational week with wet lung

Additional relevant MeSH terms:
Tachypnea
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 22, 2017