CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

Respiratory Distress Syndrome Clinical Trial

— NICA  

Official title:

Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670732
• Other study ID #: 1010049
• Secondary ID: WIH 17-0037
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: Women and Infants Hospital of Rhode Island
• Contact: Martin Keszler, MD
• Phone: 401 274 1122
• Email: mkeszler[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.

Description:

This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants < 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Gestational Age 23-34 completed weeks

• Stable on non- invasive respiratory support for at least 24h

• CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O

• FiO2 requirement of <0.40

Exclusion Criteria:

• Clinical instability as judged by the clinical team

• FiO2 requirement of > 0.40 for more than 60 min.

• >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.

• Anticipated intubation within next 24 h.

• Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).

• Hemodynamically significant patent ductus arteriosus (PDA)

• Anticipated weaning off non-invasive support in the next 24 h.

• Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias

• Lack of study equipment or personnel

• Lack of parental consent

Related Conditions & MeSH terms

• Apnea of Prematurity
• Premature Birth
• Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• continuous positive airway pressure
Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
• nasal intermittent positive pressure ventilation
NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

Locations

Country	Name	City	State
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Apnea/bradycardia events	Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor	Duration of intervention (12 hours)
Secondary	Number of of desaturation events	Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor	Duration of intervention (12 hours)
Secondary	Mean oxygen saturation by pulse oximetry and proportion of time below 88%	Mean oxygen saturation by pulse oximetry and proportion of time at saturation <88%	Duration of intervention (12 hours)
Secondary	Mean transcutaneous PCO2 and proportion of time >55 torr	Mean transcutaneous PCO2 and proportion of time at PCO2 > 55 torr	Duration of intervention (12 hours)
Secondary	Mean fraction of inspired oxygen	Mean fraction of inspired oxygen (FIO2)	Duration of intervention (12 hours)
Secondary	Mean respiratory rate	Mean respiratory rate	Duration of intervention (12 hours)
Secondary	Mean degrees of phase lag by RIP	Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography	Duration of intervention (12 hours)
Secondary	Number of episodes of feeding intolerance	number of instances of interruption of feeding, abdominal radiographs	Duration of intervention (12 hours)
Secondary	Instances of treatment failure	Inability to tolerate assigned treatment by pre-defined criteria	Duration of intervention (12 hours)