NCT01499238

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 26, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

December 14, 2011

Last Update Submit

December 21, 2011

Conditions

Transient Tachypnea of Newborn

Keywords

Efficacysafetynasal SIMVnasal CPAPinfants who are >35 gestational week with wet lung

Outcome Measures

Primary Outcomes (1)

  • efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age

    3 months

Secondary Outcomes (1)

  • Complications of respiratory support, respiratory insufficiency

    3 months

Study Arms (2)

nasal SIMV

ACTIVE COMPARATOR

rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40%

Device: Nasal SIMV

nasal CPAP

ACTIVE COMPARATOR

PEEP: 4-6 mmHg, Fio2: 40%

Device: nasal CPAP

Interventions

Nasal SIMVDEVICE

rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%

Also known as: nasal SIMV, SLE 5000
nasal SIMV
nasal CPAPDEVICE

PEEP: 4-6 mmHg, FİO2: 40%

Also known as: NASAL CPAP, SLE 5000
nasal CPAP

Eligibility Criteria

Age2 Hours - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \>35 gestational week
  • wetlung

You may not qualify if:

  • major congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gamze Demirel, MD

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Demirel, MD

CONTACT

kgamze@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity Teaching Hospital

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 26, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

December 26, 2011

Record last verified: 2011-12

Locations

TU(2)