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

Transient Tachypnea of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01499238
• Other study ID #: 4
• Status: Recruiting
• Phase: Phase 4
• First received: December 14, 2011
• Last updated: December 21, 2011
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2011
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Gamze Demirel, MD
• Email: kgamze[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• >35 gestational week

• wetlung

Exclusion Criteria:

• major congenital anomalies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of Newborn
• Transient Tachypnea of the Newborn

Intervention

Device:
• Nasal SIMV
rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FIO2: 40%
• nasal CPAP
PEEP: 4-6 mmHg, FIO2: 40%

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age		3 months	Yes
Secondary	Complications of respiratory support, respiratory insufficiency	pneumothorax	3 months	Yes