Surfactant Administration During Spontaneous Breathing

Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01329432

Acronym

TAKE CARE

Enrollment

100

Registered

2011-04-06

Start date

2010-12-31

Completion date

2011-12-31

Last updated

2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Pneumothorax, Pulmonary Interstitial Emphysema

Keywords

surfactant, intubation, spontaneous breathing, bronchopulmonary dysplasia

Brief summary

Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.

Detailed description

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. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.

Interventions

PROCEDURETake care

PROCEDUREInSurE

infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 35 Weeks

Healthy volunteers

Inclusion criteria

* All infants who presented with clinical anl laboratory signs of RDS

Exclusion criteria

* infants who required intubation or PPV right after birth

Design outcomes

Primary

Measure	Time frame
nasal cPAP failure and need for mechanical ventilation within 72 hours	first 72 hours

Secondary

Measure	Time frame
incidence of bronchopulmonary dysplasia	8-10 weeks

Countries

Turkey (Türkiye)

Contacts

Primary ContactGozde Kanmaz, MD

gzdekanmaz@yahoo.com+90 505 588 11 89

Backup ContactOmer Erdeve, MD

omererdeve@yahoo.com+90 312 306 56 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026