Premature InfantNCT03852641
Feeding Premature Infants During Non-invasive Respiratory Support
A study testing Length of feeding in people with Premature Infant and Non-invasive Respiratory Support, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant, Non-invasive Respiratory Support
- What is being tested?
- Length of feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2017to Jun 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants <1500gr, on non-invasive respiratory support
- Feeding>20 ml/kg/day
Who cannot join
- Major congenital malformations
- Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
- Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Liron Borenstein-Levin, MD, 972542243556, L_BORENSTEIN@rambam.health.gov.il
About this study
Official title: Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
- Conditions
- Premature Infant, Non-invasive Respiratory Support
- Being tested
- Length of feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Length of feedingOther
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr
| Study group | Role | What they receive |
|---|---|---|
| Bolus gavage feeds | Experimental | Bolus gavage feeds over 15-30 minutes Receives: Other: Length of feeding |
| Continuous feeds | Experimental | Continuous feeds over 2.0 hrs Receives: Other: Length of feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation instability as documented by oxygen saturation histograms
Measured: before dischatge home at an average of 40 weeks gestation
Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day
Measured: before dischatge home at an average of 40 weeks gestation
Secondary outcomes (2)
Respiratory-length of respiratory support
Measured: before dischatge home at an average of 40 weeks gestation
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team
Measured: before dischatge home at an average of 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Oct 2017
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liron Borenstein MD, Rambam Health Care Campus
- Investigators
- Liron Borenstein-Levin, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852641
- Sponsor's protocol ID
- Feeding on NIPPV
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding
- ClinicalTrials.gov ID
- NCT03852641
- Acronym / sponsor ID
- Feeding on NIPPV
- Conditions
- Premature Infant, Non-invasive Respiratory Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 25 Feb 2019 (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.
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus gavage feeds | Experimental | Other: Length of feedingBolus gavage feeds over 15-30 minutes |
| Continuous feeds | Experimental | Other: Length of feedingContinuous feeds over 2.0 hrs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants <1500gr, on non-invasive respiratory support
- Feeding>20 ml/kg/day
Key exclusion criteria (3 listed)
- Major congenital malformations
- Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
- Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).
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 |
|---|---|---|
| Length of feedingFeeds will be given via nasogastric tube over 15-30 min versus 2 hr | Other | Bolus gavage feeds, Continuous feeds |
Primary outcome
Oxygenation instability as documented by oxygen saturation histograms
Time frame: before dischatge home at an average of 40 weeks gestation
Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day
Time frame: before dischatge home at an average of 40 weeks gestation
2 secondary outcomes
Respiratory-length of respiratory support
Time frame: before dischatge home at an average of 40 weeks gestation
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team
Time frame: before dischatge home at an average of 40 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Premature Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Liron Borenstein-Levin, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Length of feeding in people with Premature Infant and Non-invasive Respiratory Support, run by Rambam Health Care Campus at 1 site in Israel.
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 2 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 25 Feb 2019. 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 Israel. 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 Liron Borenstein-Levin, MD (04-7774125, liron.boren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation instability as documented by oxygen saturation histograms (time frame: before dischatge home at an average of 40 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.