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

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ClinicalTrials.gov Identifier: NCT01499238
Recruitment Status : Unknown
Verified December 2011 by Gamze Demirel, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
First Posted : December 26, 2011
Last Update Posted : December 26, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Condition or disease Intervention/treatment Phase
Transient Tachypnea of Newborn Device: Nasal SIMV Device: nasal CPAP Phase 4

Detailed Description:
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : December 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : March 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Complications of respiratory support, respiratory insufficiency [ Time Frame: 3 months ]
    pneumothorax


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: December 26, 2011
Last Verified: December 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