Minimally Invasive Surfactant Therapy Followed by CPAP (MISTCPAP) in Preterm Infants With RDS

NCT01723683 | Unknown Phase 2 DMC

• 1 other identifier: DMR101-IRB2-221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD since the development of Surfactant therapy. A policy of intubation with surfactant administration and mechanical ventilation has become a standard therapy of infants at high risk of RDS. However, initial stabilization with CPAP and, if necessary, given rescue surfactant therapy has remained the standard therapy for preterm infants. Evidence reveals similar results with regard to mortality and neonatal morbidity between the above two strategies. The investigators intend to develop a method of minimally invasive surfactant therapy followed by early CPAP (MISTCPAP) in preterm Infants with high risk of RDS for improving the outcomes and reducing the incidence of BPD.

Conditions

Respiratory Distress Syndrome

Keywords

Preterm infants; RDS; Surfactant; MISTCPAP; CPAP

Outcome Measures

Primary Outcomes (1)

• Requirement of rescue intubation and mechanical ventilation

  Failure of MISTCPAP procedure: SA1. Need for invasive ventilation, requiring either FiO2\> 0.6 or pCO2\> 65 mm Hg and pH \< 7.20 or both for more than 2 hours after surfactant administration up to 72 hrs of life 2. Intubation/requirement for mechanical ventilation within 48h after first intervention (same criteria as above:requiring either FiO2\> 0.6 or pCO2\> 65 mm Hg and pH \< 7.20 or both for more than 2 hours) 3. Acute deterioration during immediate intervention leading to intubation (e.g. severe bradycardia/resuscitation, pneumothorax) Failure for INSURE procedure: 1\. Failed extubation within 15 min after intubation for surfactant application

  72 hours

Secondary Outcomes (7)

• 1.Incidence of grade 3 /4 IVH (intraventricular hemorrhage),PVL (periventricular leucomalacia),ROP (retinopathy of prematurity) requiring treatment,NEC (necrotizing enterocolitis)stage 2 and 3

  8 weeks of life

• 2.Total duration of invasive and non-invasive ventilation (the extubation and weaning will follow the NICU guidelines), duration of oxygen supplementation until discharge

  participants will be followed for the duration of hospital stay, an expected average of 8 weeks

• 3.Proportion of patients requiring oxygen supplementation at discharge 3.Proportion of patients requiring oxygen supplementation at discharge

  participants will be followed for the duration of hospital stay, an expected average of 8 weeks

• 4.Proportion of surfactant related adverse events like tube blockade, episodes of desaturation, bradycardia, pulmonary hemorrhage, pneumothorax differ in the two groups

  1 wk of life

• 5.Total number of surfactant doses required compared in the two groups

  1 week of life

Study Arms (2)

MISTCPAP group

EXPERIMENTAL

MISTCPAP group: Surfactant will be instillated via the Angio-Cath without endotracheal intubation and followed by CPAP.

Drug: Surfactant

INSURE group

ACTIVE COMPARATOR

INSURE group: The procedure of surfactant treatment should be according to the conventional surfactant treatment which involves intubation, surfactant divided to 4 liquors to inject into 4 positions followed by amubagging and then extubation to CPAP.

Drug: Surfactant

Interventions

Surfactant DRUG

INSURE group; MISTCPAP group

Eligibility Criteria

• Age: 1 Hour - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very preterm infants (GA \< 32 wks) admitted to NICU at CMUH from 1 February 2012 to 31 January 2013 are enrolled for the study
• Less than 36 hours of age
• Clinical signs of RDS with requirement of FiO2 ≥ 0.35

You may not qualify if:

• Previous Intubation or in imminent need of IMV because of e.g. apnea, severe bradycardia or other deterioration not attributed to RDS, e.g. shock
• Major congenital malformations
• No parental consent

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Children's Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Bai-Horng Su, MD, PhD

  Dept. of Pediatrics, China Medical University Hospital

  STUDY CHAIR

• Hsieh-Yu Lin, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bai-Horng Su, MD, PhD

CONTACT

886-4-22052121; subh1168@gmail.com

Hsieh-Yu Lin, MD

CONTACT

886-4-22052121; hsyulin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 8, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

TW (1)