Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants

NCT02055339 | Completed

• 1 other identifier: MountSinaiH
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not started due to concerns for choking. This may cause them to miss their window of learning and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of ventilators, but no studies have been done in older babies. We plan to compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time to full oral feeds.

Conditions

Feeding Behavior; Chronic Lung Disease

Outcome Measures

Primary Outcomes (1)

• Time to reach full oral feeds

  2 months

Secondary Outcomes (4)

• Time on non-invasive ventilation or oxygen

  2 months

• Occurrence of feeding intolerance or reflux

  2 months

• Occurrence of apneas/bradycardias/desaturations above baseline

  2 months

• Weight gain

  2 months

Study Arms (2)

Fisher & Paykel heated humidified high flow nasal cannula

EXPERIMENTAL

For neonates randomized to HHHFNC, they will be placed on a flow rate equivalent to the pressures of nCPAP they were originally receiving based on a published chart, or stay on the same flow rate prior to randomization. When it is time for oral feeds, the Registered Nurse (RN) will turn the dial of the high flow circuit down to 2 lpm. The baby will then proceed to feed for up to one hour, and afterwards, will be turned back up to the flow rate they were on prior to feeds.

Device: Fisher & Paykel heated humidified high flow nasal cannula

InfantFlow/RAM nasal continuous positive airway pressure

ACTIVE COMPARATOR

Neonates randomized to the nCPAP arm will remain on the nCPAP pressures they were on before recruitment into the study or match the flow rate they were receiving on high flow based on a published chart. The nCPAP circuit will only be removed when it is time for oral feeds. The respiratory therapist (RT) will exchange the circuit for a low flow nasal cannula which will be set at the flow that is optimal for the baby's gestational age saturations. The baby will then proceed to feed for up to one hour, and afterwards, will be changed back to the nCPAP circuit.

Device: InfantFlow/RAM nasal continuous positive airway pressure

Interventions

Fisher & Paykel heated humidified high flow nasal cannula DEVICE

Fisher & Paykel heated humidified high flow nasal cannula

InfantFlow/RAM nasal continuous positive airway pressure DEVICE

InfantFlow/RAM nasal continuous positive airway pressure

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age of \<28 weeks (24+0 to 27+6) with corrected gestational age of 34 weeks
• Neonates requiring respiratory support in the form of nCPAP or HHHFNC at any pressure at 34 weeks corrected gestational age and failing a trial of low flow oxygen or room air
• Full enteral feeding tolerated through a nasogastric tube

You may not qualify if:

• Gestational age \> 28 weeks
• Neonate requiring biphasic nCPAP
• Mother never at the bedside and no consent for bottle feeds
• Severe nasal breakdown or genetic/neurologic abnormalities which impair oral feeding

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital NICU

Toronto, Ontario, Canada

Location

Related Publications (1)

• Leibel SL, Castro M, McBride T, Hassall K, Sarmiento K, Ye XY, Shah V. Comparison of Continuous positive airway pressure versus High flow nasal cannula for Oral feeding Preterm infants (CHOmP): randomized pilot study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):951-957. doi: 10.1080/14767058.2020.1735339. Epub 2020 Mar 5.

  PMID: 32138561 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Sandra Leibel, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Neonatologist

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 5, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 9, 2018

Record last verified: 2018-11

Locations

CA (1)