Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants

NCT01741129 | Completed Phase 4

• 1 other identifier: ZTB2611
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.

Conditions

Noninvasive Ventilation for Respiratory Distress Syndrome

Keywords

Nasal CPAP; Nasal IMV; Surfactant; Preterm infants

Outcome Measures

Primary Outcomes (1)

• Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants

  If infants needed invasive MV or Required a fraction of inspired oxygen of \>40% to maintain the targeted saturation of \>88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.

  3 months

Secondary Outcomes (1)

• Complications of respiratory support

  3 months

Study Arms (2)

Nasal Continuous Positive Airway Pressure (CPAP)

ACTIVE COMPARATOR

After 2 hours evaluation: * Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of \>40% to maintain the targeted saturation of \>88% to 92%. * Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose

Device: Nasal CPAP (SLE)

Nasal Intermittent Mandatory Ventilation (IMV)

ACTIVE COMPARATOR

After 2 hours evaluation: * Infants needed invasive MV or Required a fraction of inspired oxygen of \>40% to maintain the targeted saturation of \> 88% to 92%. * Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose

Device: Nasal IMV (SLE)

Interventions

Nasal CPAP (SLE) DEVICE

PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute

Also known as: SLE 2000, SLE 5000

Nasal Continuous Positive Airway Pressure (CPAP)

Nasal IMV (SLE) DEVICE

PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute

Also known as: SLE 2000, SLE 5000

Nasal Intermittent Mandatory Ventilation (IMV)

Eligibility Criteria

• Age: Up to 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Gestational age 26-32 weeks
• The criteria for failure were met by at least 1 of the following:
• pH: 7.10 and PaCO2: 70 mm Hg
• Recurrent apnea with \>3 episodes (Prophylactic caffeine were used in all infants)
• Single episode of apnea that required bag-and-mask ventilation
• PaO2: 50 mmHg with a fraction of inspired oxygen of \>0.5.

You may not qualify if:

• Major congenital anomalies
• Presence of cardiovascular instability
• Intubation at admission to the NICU
• Consent not provided or refused

Sponsors & Collaborators

• Mehmet Yekta: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.

  PMID: 26553376 DERIVED

Study Design

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

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 10, 2014

Record last verified: 2013-01

Locations

TU (1)