Surfactant Administration During Spontaneous Breathing (TAKE CARE)
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ClinicalTrials.gov Identifier: NCT01329432 |
Recruitment Status : Unknown
Verified December 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was: Recruiting
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumothorax Pulmonary Interstitial Emphysema Bronchopulmonary Dysplasia | Procedure: Take care Procedure: InSurE | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study |
Study Start Date : | December 2010 |
Estimated Primary Completion Date : | January 2011 |
Estimated Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: take care
In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing
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Procedure: Take care
In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. |
Experimental: InSurE
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration
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Procedure: InSurE
infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. |
- nasal cPAP failure and need for mechanical ventilation within 72 hours [ Time Frame: first 72 hours ]
- incidence of bronchopulmonary dysplasia [ Time Frame: 8-10 weeks ]

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Ages Eligible for Study: | 23 Weeks to 35 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All infants who presented with clinical anl laboratory signs of RDS
Exclusion Criteria:
- infants who required intubation or PPV right after birth

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): NCT01329432
Contact: Gozde Kanmaz, MD | +90 505 588 11 89 | gzdekanmaz@yahoo.com | |
Contact: Omer Erdeve, MD | +90 312 306 56 76 | omererdeve@yahoo.com |
Turkey | |
Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit | Recruiting |
Ankara, Turkey, 06100 | |
Contact: Gozde Kanmaz, MD + 90 505 588 11 89 gzdekanmaz@yahoo.com | |
Contact: Omer Erdeve, MD +90 312 306 56 76 omererdeve@yahoo.com | |
Principal Investigator: Gozde Kanmaz, MD | |
Sub-Investigator: Banu Mutlu, MD |
Responsible Party: | Gozde Kanmaz, MD, Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit |
ClinicalTrials.gov Identifier: | NCT01329432 |
Other Study ID Numbers: |
2011-019 |
First Posted: | April 6, 2011 Key Record Dates |
Last Update Posted: | April 6, 2011 |
Last Verified: | December 2010 |
surfactant intubation spontaneous breathing bronchopulmonary dysplasia |
Respiratory Aspiration Bronchopulmonary Dysplasia Pneumothorax Emphysema Respiration Disorders Respiratory Tract Diseases Pathologic Processes |
Lung Diseases Ventilator-Induced Lung Injury Lung Injury Infant, Premature, Diseases Infant, Newborn, Diseases Pleural Diseases |