Different Levels of BiPAP

NCT06421519 | Recruiting Phase 1

• 1 other identifier: IRAS 327794
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing. The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure (BiPAP), a support which gives two levels of support (pressure) to premature infants. The study is investigating which upper pressure gives the best support, that is results in the baby having to breathe less hard (work of breathing). Researchers will measure the work of breathing using a small catheter. Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each. In between each upper level they will receive the standard upper pressure for 20 minutes.

Conditions

Bronchopulmonary Dysplasia

Keywords

Biphasic continuous positive airway pressure (BiPAP)

Outcome Measures

Primary Outcomes (2)

• Work of breathing

  Oesophageal (Poes) and gastric pressures(Pgas) will be measured using a catheter with dual pressure tipped transducers (Gaeltec, Dunvegan, Scotland, UK). Transdiaphragmatic pressure (PTPdi) will be calculated by digital subtraction of the oesophageal from the gastric pressure and tidal volume obtained by digital integration of the flow signal by the acquisition software. The mean PTPdi will be calculated from 20 consecutive breaths to measure work of breathing.

  Over the last 5 minutes of the 20 minute study period on each setting of BiPAP

• Work of breathing

  Transcutaneous diaphragm electromyography (EMG) will be monitored using a portable 16-channel digital physiological amplifier (Dipha-16; Inbiolab, Groningen, the Netherlands) and three surface electrodes (Kendall H59P cloth electrodes; Covidien, Massachusetts) placed on the infant's abdomen. The device wirelessly transmits to a bedside computer running Polybench (Applied Biosignals, Weener, Germany). Work of breathing will be calculated using the voltages measured from a 5 minute period of recording.

  Over the last 5 minutes of the 20 minute study period on each setting of BiPAP

Study Arms (3)

Pre-term infants requiring primary respiratory support before intubation

EXPERIMENTAL

Infants \<34 weeks gestational age who require non-invasive respiratory support who may go on to require invasive ventilation.

Other: BiPAP setting

Pre-term infants requiring respiratory support after extubation

EXPERIMENTAL

Infants \<34 weeks gestational age who were previously invasively ventilated and are currently being weaned onto non-invasive respiratory support and eventually into self-ventilating in room air.

Other: BiPAP setting

Pre-term infants requiring respiratory support after seven days

EXPERIMENTAL

Infants \<34 weeks gestational age who have an ongoing need for non-invasive respiratory support after seven days of life and are likely to develop bronchopulmonary dysplasia.

Other: BiPAP setting

Interventions

BiPAP setting OTHER

Infants in this arm of the study will each rotate through three different BiPAP settings. The following BiPAP settings will be used: 13cmH2O / 5cmH2O, 10cmH2O / 5cmH2O, 7cmH2O / 5cmH2O

Pre-term infants requiring primary respiratory support before intubation; Pre-term infants requiring respiratory support after extubation; Pre-term infants requiring respiratory support after seven days

Eligibility Criteria

• Age: 2 Days - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born \<34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days
• Infants aged between 2 days and 2 months at time of study

You may not qualify if:

• Infants with congenital abnormalities of the respiratory system.
• Infants with blood-culture confirmed sepsis.
• Recent gastrointestinal surgery (within 7 days)
• Non-English speakers

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Theodore Dassios

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oishi Sikdar

CONTACT

07901931550; oishi.sikdar2@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During the study the infant and their parents will not be aware of which pressures they are on. Due to the nature of the study it is not possible to blind the care provider who in this case is the investigator since they need to manipulate the ventilator settings. However, data analysis with be done using anonymous data and the investigator will be blinded to which pressure settings were used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Infants receive receive three upper pressures of BiPAP: 7, 10 or 13cmH2O for a period of 20 minutes each. Additionally, there will be a control period of 20 minutes between each upper pressure with a baseline pressure constant of 5cmH2O. The order in which they receive the levels of respiratory support will be randomised using an excel random number generator. This allows each infant to be used as their own control, minimising the impact of any underlying confounding factors. The results on each pressure setting will be meaned and compared to each other

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 20, 2024
• Study Start: May 23, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

GB (1)