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NCT Number: NCT06295484

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Background:

In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.

The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.

Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.

One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Lungs Respiratory Distress Syndrome in Premature Infant Urogenital Diseases

Age range

1 day–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Maher Shahroor, MD

CONTACT

[email protected]

(416) 480-6100 ext. 687939

About this study

Our main goal in this study:

To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV.

Inclusion criteria

(Potential Candidates):

This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP.

The steps of the study:

The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. The investigators will continue to record the Edi signals during the 3 methods.

Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, the participant's baby will be put back to the originally prescribed breathing support.

Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)
  • Birth weight less than 1500 grams
  • Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen

Exclusion criteria

  • Congenital anomalies of the gastrointestinal tract
  • Phrenic nerve damage
  • Diaphragmatic paralysis
  • Esophageal perforation
  • Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure
  • Significant congenital heart disease (including symptomatic PDA)
  • Congenital anomalies of the diaphragm
  • Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM')
  • Ongoing treatment for sepsis
  • Ongoing treatment for necrotizing enterocolitis (NEC)
  • Ongoing treatment for lung infections
  • Narcotic analgesics
  • Gastric motility agents
  • Infants on nasal CPAP and requiring more than 35% oxygen
  • Infants with significant gastric residuals and vomiting
  • Infants with facial anomalies
  • Infants with pneumothorax or pneumomediastinum
  • Infants in the immediate postoperative period

Treatment and study plan

Alternating traditional CPAP, NIPPV, and high CPAP

Other

The investigators will continue to record the Edi signals during the 3 methods (traditional CPAP, NIPPV, and high CPAP)

Primary outcomes

  1. The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O).

    Time frame: 2 hours per each mode of ventilation, total of 6 hours Edi recording

Secondary outcomes

  1. 1. Neural respiratory rate per minute

    Time frame: 2 hours per each mode of ventilation, total of 6 hours

  2. 2. Edi peak measured in MicroVoltage

    Time frame: 2 hours per each mode of ventilation, total of 6 hours

  3. 3. The difference in transcutaneous pCO2 in mmHg

    Time frame: 2 hours per each mode of ventilation, total of 6 hours

  4. 4. The difference in oxygen requirements in percent (i.e, 21%)

    Time frame: 2 hours per each mode of ventilation, total of 6 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Maher Shahroor, MD

CONTACT

[email protected]

(416) 480-6100 ext. 687939

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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