Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02055339
Other study ID # MountSinaiH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date December 2016

Study information

Verified date November 2018
Source Mount Sinai Hospital, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The primary objective of this study is to assess whether a baby born at less than 28 weeks gestation who at 34 weeks corrected gestational age, will reach full oral feeds faster on the current practice of nasal continuous positive airway pressure (nCPAP) and low flow oxygen (LFO2) or the new intervention of heated, humidified high flow nasal cannula (HHHFNC).

The specific aim of this study is to investigate the effectiveness and safety of using nCPAP and LFO2 versus HHHFNC for reaching full oral feeds in premature infants.

We hypothesize that the use of HHHFNC at the initiation of oral feeding will allow babies to reach full feeds sooner as compared with nCPAP and LFO2.

Babies born at extreme prematurity (<28 weeks gestation), are at risk of chronic lung disease due to lung immaturity. A proportion of preterm infants remains dependent on non-invasive ventilation at the corrected gestational age when they are at the neurodevelopmental stage of oral feeds. If oral feeds are not initiated in a timely manner, delays in progression of oral feeds and oral aversion may occur, resulting in longer hospital stays and/or gastrostomy tube insertions. Those that are nCPAP dependant are unable to orally feed due to safety concerns so are placed on a low pressure system of low flow nasal cannula during feeds. This may lead to microatelectasis in those babies needing a higher pressure to maintain gas exchange. HHHFNC is another method of non-invasive ventilation and it can be changed from a high pressure system (in litres per minute) to a low pressure system by turning a dial, and not having to disconnect the baby from the respiratory system.

Randomized controlled trial consisting of two arms: 1) The CPAP/LFO2 arm in which the babies will be maintained on nCPAP until the time of oral feeds wherein they will have their circuits exchanged for a low flow cannula. 2) The HHHFNC arm in which babies will be maintained on 5 lpm of HHHFNC until the time of oral feeds, wherein they will have their flows turned down to 2 lpm. The study will be conducted in a level III neonatal intensive care unit (NICU) in Mount Sinai hospital. The study subjects are 40 preterm babies that were born before 28 weeks gestational age who are now 34 weeks corrected gestational age (CGA), which are dependent on non-invasive ventilation and are receiving full feeds via nasogastric tube. The randomization will occur at 33+6/7 weeks CGA. Demographic characteristics will be compared between groups using Chi-square test or Fisher's exact test for categorical variables. Differences between continuous variables will be assessed using Student's t-test or Mann-Whitney U test for non-normally distributed variables. The primary outcome (time to full oral feeds) is a binary outcome and will be compared between groups using Chi-square test or Fisher's exact test. A difference of a p-value of <0.05 will be considered significant.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 32 Weeks to 34 Weeks
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fisher & Paykel heated humidified high flow nasal cannula

InfantFlow/RAM nasal continuous positive airway pressure


Locations

Country Name City State
Canada Mount Sinai Hospital NICU Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reach full oral feeds 2 months
Secondary Time on non-invasive ventilation or oxygen 2 months
Secondary Occurrence of feeding intolerance or reflux 2 months
Secondary Occurrence of apneas/bradycardias/desaturations above baseline 2 months
Secondary Weight gain 2 months
See also
  Status Clinical Trial Phase
Completed NCT04502979 - Learning to Love Mealtime Together N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Completed NCT03651258 - Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03949543 - The Timing of Main Meal Consumption Effect on Gut Microbiota and Host N/A
Not yet recruiting NCT05059574 - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies N/A
Completed NCT03242863 - Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children N/A
Completed NCT03127579 - Family Meal Duration and Children's Eating Behavior N/A
Completed NCT02996422 - Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky N/A
Enrolling by invitation NCT03755999 - A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period N/A
Recruiting NCT03439618 - Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients N/A
Completed NCT03488680 - Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants N/A
Recruiting NCT04960969 - The Effects of Time-Restricted Eating Model N/A
Completed NCT02930642 - Food Insecurity, Obesity, and Impulsive Food Choice N/A
Completed NCT03926065 - Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children N/A
Completed NCT03886428 - The Influence of Satiation Measures on the Portion Size Effect N/A
Completed NCT03025815 - Effects of the Oral Stimulation Program in Extreme Preterm Infants N/A
Completed NCT02347527 - Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals N/A