Prematurity; ExtremeNCT05824377
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
A study testing Continuous Feeds and Intermittent Bolus Feeds in people with Prematurity; Extreme and Feeding Patterns, run by Rajeev Kumar at 1 site in United States.
Trial summary
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prematurity; Extreme, Feeding Patterns, Ventilator Lung; Newborn
- What is being tested?
- Continuous Feeds and Intermittent Bolus Feeds
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preterm Infants 24- 34 weeks of gestation
- On Non-invasive ventilation (NIPPV/CPAP/HFNC)
- Nothing by mouth (NPO) or on trophic feeds (<20 ml/kg/day) at the time of randomization.
Who cannot join
- Gestational Age > 34 weeks
- Infants on invasive ventilation or low flow nasal cannula and on feeding volume more than trophic feeds.
- Major congenital anomalies.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cook County Helath
Chicago, Illinois, 60612
Rajeev Kumar, MD
Rajeev Kumar, MD
About this study
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
Read the detailed description
Methods:
The study will be a randomized control trial at our NICU (Neonatal Intensive Care Unit) (Level III). Preterm infants on non -invasive ventilation (nasal intermittent positive pressure ventilation (NIPPV)/ continuous positive airway pressure (CPAP)) will be randomly assigned into either continuous feeds or bolus feeds groups. Baby will be fed enterally through a nasogastric tube via continuous or bolus feeds using either maternal milk or formula, according to parental choice. Feeds will be advanced as per the feeding guidelines or per treating physician. Currently we use both bolus and continuous feeding practice in our NICU, as per physician's discretion.
Intervention:
Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump. Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.
Parents' consent will be taken when the infant is qualified for the study. The consent will be taken by one of the coinvestigators. Each coinvestigator will be trained to consent for standardization. Non-English-speaking parents will be consented using the medical video interpreter (Voyce). Accent will not be obtained as neonates aren't mature to give accent.
Patients will be randomized into each group by pulling a sealed envelope.
Monitoring for complications:
During the study, infants will be monitored for any complications due to either feeding protocol like feeding intolerance, reflux, abdominal distension, poor weight gain, any risk of aspiration pneumonia or necrotizing enterocolitis (NEC). Such symptoms are usually monitored by our NICU team as per our guidelines. These feeding issues can be encountered in either group. If such problems are encountered, feeding protocol will be changed as per the physician's clinical decision. Parents will be informed of the changes. Intention to treat protocol will be used while calculating the statistical analysis.
Guidelines for withholding the feeds (bolus or intermittent) or changing either group will be:
- Excessive gastric residual (> 50% of the volume fed)
- Increase in abdominal girth (>1.5-2.5 cm along with other signs and symptoms of intolerance to feeds)
- Poor/slow weight gain (rate of weight gain is significantly below that expected for age and sex, or if weight has dropped ≥2 major percentile lines)
- Occult blood positive in stools/visible blood in the stools
- Concerns for neonatal sepsis clinically as per attending's discretion
- Apnea pertaining for more than 20 secs alone or apnea for > 10 seconds along with bradycardia (<80) or desaturations (hypoxemia as per gestational age); and occurring more than 2 or 3 times a day and requiring intervention
- Abnormal Abdominal X rays concerning for suspected NEC or NEC as per Bell's criteria
- Infants who need to be on invasive ventilation
- Treating physician's clinical decision
Feeding protocol:
BW: 500 -1000 grams:
Initiate: When baby is stable. Start with trophic feeds, that is, 5 -10 ml/kg/day.
Advance: If tolerating trophic feeds for 2-3 days, advance feeds by 10 ml/kg/day.
Initial choice of milk: Breast Milk/Donor Breast Milk / Formula (Enfamil) - 20Kcal/Oz.
Fortify: When 60-80 ml/kg/day feeds are reached, fortify to 22Kcal/Oz and within next few days to 24 Kcal/Oz.
BW 1000 - 1500 grams:
Initiate: When baby is stable. Trophic feeds 5-10 ml/kg/day. Advance: 15-20 ml/kg/day Initial choice of milk, fortifying and full feeds as above.
BW 1500 grams and above:
Initiate: 30 ml/kg/day. Advance: 20 -35 ml/kg/day Initial choice of milk, fortifying and full feeds as above.
- Being tested
- Continuous Feeds, Intermittent Bolus Feeds
- Keywords
- Preterm infants, Feeding methods, bolus feeds, continuous feeds, non-invasive ventilation, RAM cannula
- Medical subject headings
- Premature Birth, Feeding Behavior, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous FeedsOther
Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump.
Intermittent Bolus FeedsOther
Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Bolus Feeding | Experimental | Intermittent bolus feeding will be defined as delivering enteral nutrition multiple times, usually every 2-3 hours over 15 - 30 minutes by gravity or an electric pump.
It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g). Receives: Other: Intermittent Bolus Feeds |
| Continuous Feeding | Experimental | Continuous feeding will be defined as delivering enteral nutrition with constant speed for 24 hours via a nutritional pump.
It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g). Receives: Other: Continuous Feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of life to reach full feeds
the day of life to reach full feed, that is, 120 ml/kg/day.
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Secondary outcomes (5)
Feeding interruptions
Interruptions while feeding, which includes NPO days, Lab usage and Radiological evaluation.
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Time to reach (day of life) first oral feed
Day of life when infant was taking oral feeds (no feeds by nasogastric tube)
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Weight gain, head circumference (HC) and Length.
Anthropometric parameters
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Length of hospital stay
Total duration of hospital stay
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Use of investigative medicine for feeding intolerance
Use of radiographic imaging or blood work-up to rule out any feeding intolerance
Measured: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Each group will be stratified as per weight, thus (\<1000 g, 1000-1500 g, and \> 1500 g). It will be 1-1 randomization and will be randomized into each group by pulling a sealed envelope. Protected Health Information (PHI) will be de-identified by assigning a study code. Sample size: A sample size of at least 23 in each arm was calculated using the SAS system. A power of 80% and a mean difference of 40% decrease in the length of time to achieve full feeds; and an SD of 8.5 was considered while calculating the number of patients. The mean length of time to achieve full feeds in our NICU as per chart review was 17 +/- 8.5 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajeev Kumar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Rajeev Kumar, Cook County Health
- Investigators
- Rajeev Kumar, MD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824377
- Sponsor's protocol ID
- 22-058
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cresi F, Maggiora E, Borgione SM, Spada E, Coscia A, Bertino E, Meneghin F, Corvaglia LT, Ventura ML, Lista G; ENTARES Study Research Group. Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):67. doi: 10.1186/s13063-018-3119-0.
PubMed 30658676Wang Y, Zhu W, Luo BR. Continuous feeding versus intermittent bolus feeding for premature infants with low birth weight: a meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2020 May;74(5):775-783. doi: 10.1038/s41430-019-0522-x. Epub 2019 Oct 28.
PubMed 31659243Mukerji A, Abdul Wahab MG, Razak A, Rempel E, Patel W, Mondal T, Beck J. High CPAP vs. NIPPV in preterm neonates - A physiological cross-over study. J Perinatol. 2021 Jul;41(7):1690-1696. doi: 10.1038/s41372-021-01122-6. Epub 2021 Jun 5.
PubMed 34091605Premji SS, Chessell L. Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 grams. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD001819. doi: 10.1002/14651858.CD001819.pub2.
PubMed 22071802Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.
PubMed 32086439Akintorin SM, Kamat M, Pildes RS, Kling P, Andes S, Hill J, Pyati S. A prospective randomized trial of feeding methods in very low birth weight infants. Pediatrics. 1997 Oct;100(4):E4. doi: 10.1542/peds.100.4.e4.
PubMed 9310537
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
- ClinicalTrials.gov ID
- NCT05824377
- Acronym / sponsor ID
- 22-058
- Keywords
- Preterm infants, Feeding methods, bolus feeds, continuous feeds, non-invasive ventilation, RAM cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Rajeev KumarOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
Detailed description
Methods:
The study will be a randomized control trial at our NICU (Neonatal Intensive Care Unit) (Level III). Preterm infants on non -invasive ventilation (nasal intermittent positive pressure ventilation (NIPPV)/ continuous positive airway pressure (CPAP)) will be randomly assigned into either continuous feeds or bolus feeds groups. Baby will be fed enterally through a nasogastric tube via continuous or bolus feeds using either maternal milk or formula, according to parental choice. Feeds will be advanced as per the feeding guidelines or per treating physician. Currently we use both bolus and continuous feeding practice in our NICU, as per physician's discretion.
Intervention:
Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump. Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.
Parents' consent will be taken when the infant is qualified for the study. The consent will be taken by one of the coinvestigators. Each coinvestigator will be trained to consent for standardization. Non-English-speaking parents will be consented using the medical video interpreter (Voyce). Accent will not be obtained as neonates aren't mature to give accent.
Patients will be randomized into each group by pulling a sealed envelope.
Monitoring for complications:
During the study, infants will be monitored for any complications due to either feeding protocol like feeding intolerance, reflux, abdominal distension, poor weight gain, any risk of aspiration pneumonia or necrotizing enterocolitis (NEC). Such symptoms are usually monitored by our NICU team as per our guidelines. These feeding issues can be encountered in either group. If such problems are encountered, feeding protocol will be changed as per the physician's clinical decision. Parents will be informed of the changes. Intention to treat protocol will be used while calculating the statistical analysis.
Guidelines for withholding the feeds (bolus or intermittent) or changing either group will be:
- Excessive gastric residual (> 50% of the volume fed)
- Increase in abdominal girth (>1.5-2.5 cm along with other signs and symptoms of intolerance to feeds)
- Poor/slow weight gain (rate of weight gain is significantly below that expected for age and sex, or if weight has dropped ≥2 major percentile lines)
- Occult blood positive in stools/visible blood in the stools
- Concerns for neonatal sepsis clinically as per attending's discretion
- Apnea pertaining for more than 20 secs alone or apnea for > 10 seconds along with bradycardia (<80) or desaturations (hypoxemia as per gestational age); and occurring more than 2 or 3 times a day and requiring intervention
- Abnormal Abdominal X rays concerning for suspected NEC or NEC as per Bell's criteria
- Infants who need to be on invasive ventilation
- Treating physician's clinical decision
Feeding protocol:
BW: 500 -1000 grams:
Initiate: When baby is stable. Start with trophic feeds, that is, 5 -10 ml/kg/day.
Advance: If tolerating trophic feeds for 2-3 days, advance feeds by 10 ml/kg/day.
Initial choice of milk: Breast Milk/Donor Breast Milk / Formula (Enfamil) - 20Kcal/Oz.
Fortify: When 60-80 ml/kg/day feeds are reached, fortify to 22Kcal/Oz and within next few days to 24 Kcal/Oz.
BW 1000 - 1500 grams:
Initiate: When baby is stable. Trophic feeds 5-10 ml/kg/day. Advance: 15-20 ml/kg/day Initial choice of milk, fortifying and full feeds as above.
BW 1500 grams and above:
Initiate: 30 ml/kg/day. Advance: 20 -35 ml/kg/day Initial choice of milk, fortifying and full feeds as above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Each group will be stratified as per weight, thus (<1000 g, 1000-1500 g, and > 1500 g). It will be 1-1 randomization and will be randomized into each group by pulling a sealed envelope. Protected Health Information (PHI) will be de-identified by assigning a study code. Sample size: A sample size of at least 23 in each arm was calculated using the SAS system. A power of 80% and a mean difference of 40% decrease in the length of time to achieve full feeds; and an SD of 8.5 was considered while calculating the number of patients. The mean length of time to achieve full feeds in our NICU as per chart review was 17 +/- 8.5 days.
| Arm | Type | Receives |
|---|---|---|
| Bolus Feeding | Experimental | Other: Intermittent Bolus FeedsIntermittent bolus feeding will be defined as delivering enteral nutrition multiple times, usually every 2-3 hours over 15 - 30 minutes by gravity or an electric pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g). |
| Continuous Feeding | Experimental | Other: Continuous FeedsContinuous feeding will be defined as delivering enteral nutrition with constant speed for 24 hours via a nutritional pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm Infants 24- 34 weeks of gestation
- On Non-invasive ventilation (NIPPV/CPAP/HFNC)
- Nothing by mouth (NPO) or on trophic feeds (<20 ml/kg/day) at the time of randomization.
Key exclusion criteria (3 listed)
- Gestational Age > 34 weeks
- Infants on invasive ventilation or low flow nasal cannula and on feeding volume more than trophic feeds.
- Major congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous FeedsContinuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump. | Other | Continuous Feeding |
| Intermittent Bolus FeedsIntermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes. | Other | Bolus Feeding |
Primary outcome
Day of life to reach full feeds
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
the day of life to reach full feed, that is, 120 ml/kg/day.
5 secondary outcomes
Feeding interruptions
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Time to reach (day of life) first oral feed
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Weight gain, head circumference (HC) and Length.
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Length of hospital stay
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Use of investigative medicine for feeding intolerance
Time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 30658676Cresi F, Maggiora E, Borgione SM, Spada E, Coscia A, Bertino E, Meneghin F, Corvaglia LT, Ventura ML, Lista G; ENTARES Study Research Group. Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):67. doi: 10.1186/s13063-018-3119-0.
- Background: PubMed 31659243Wang Y, Zhu W, Luo BR. Continuous feeding versus intermittent bolus feeding for premature infants with low birth weight: a meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2020 May;74(5):775-783. doi: 10.1038/s41430-019-0522-x. Epub 2019 Oct 28.
- Background: PubMed 34091605Mukerji A, Abdul Wahab MG, Razak A, Rempel E, Patel W, Mondal T, Beck J. High CPAP vs. NIPPV in preterm neonates - A physiological cross-over study. J Perinatol. 2021 Jul;41(7):1690-1696. doi: 10.1038/s41372-021-01122-6. Epub 2021 Jun 5.
- Background: PubMed 22071802Premji SS, Chessell L. Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 grams. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD001819. doi: 10.1002/14651858.CD001819.pub2.
- Background: PubMed 32086439Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.
- Background: PubMed 9310537Akintorin SM, Kamat M, Pildes RS, Kling P, Andes S, Hill J, Pyati S. A prospective randomized trial of feeding methods in very low birth weight infants. Pediatrics. 1997 Oct;100(4):E4. doi: 10.1542/peds.100.4.e4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev Kumar, MD principal investigator
Cook County Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Feeds and Intermittent Bolus Feeds in people with Prematurity; Extreme and Feeding Patterns, run by Rajeev Kumar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aashika Janwadkar, MD (6469343483, aashika.janwadkar@cookcountyhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day of life to reach full feeds (time frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824377, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.