Clinical trial NCT02014493: Changes in Respiratory Effort in Preterm Infants
Official title: Respiratory Effort in Preterm Infants in the Transition From Continuous Positive Airway Pressure (CPAP) to High Flow Nasal Cannulae (HFNC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Respiration
Noninvasive Ventilation
Work of breathing
Infant, premature
Electromyography
Diaphragm
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2013-12-18
Enrollment: 21
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child.

Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation.

There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.

Detailed description: Data material will be stored on a separate computer in a sheltered home Directory. All data will be anonymous. Edi signals are transported from Servo-I ventilator with neural access through a communication port to a personal computer.Respiratory parameters will be stored in Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory effort in transition from CPAP to HFNC".

Eligibility criteria: Inclusion Criteria:

* Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min
* \<34 and \>28 gestational weeks, respiratory stable last 72 hours.
* 1 kilo
* Fi02\< 30%
* C02\<9
* written informed consent by parents/caregivers

Exclusion Criteria:

* need for sedation
* damage on the phrenic nerve
* anomalies in the upper airways

Primary outcomes:
measure: Neural control of respiration
timeFrame: 4 months
Secondary outcomes:
measure: Respiratory signs
timeFrame: 4 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Newborn Intensive Care Unit, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Håkon Bergseng, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.