Premature InfantNCT03748472
The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants
A study testing Continuous gavage feeding and Bolus feeding in people with Premature Infant and Respiratory Disease, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant, Respiratory Disease
- What is being tested?
- Continuous gavage feeding and Bolus feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 29 May 2019to 1 Mar 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
- Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day
Who cannot join
- Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.
- Instability because of:
- Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.
- Conditions
- Premature Infant, Respiratory Disease
- Being tested
- Continuous gavage feeding, Bolus feeding
- Medical subject headings
- Premature Birth, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous gavage feedingProcedure or surgery
Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.
Bolus feedingProcedure or surgery
Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.
| Study group | Role | What they receive |
|---|---|---|
| Bolus feeding | Experimental | Not described Receives: Procedure: Bolus feeding |
| continuous gavage feeding | Experimental | Not described Receives: Procedure: Continuous gavage feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation instability
SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
Measured: 9 hours (3 feeds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start29 May 2019
- Primary completion13 Dec 2020
- Study completion1 Mar 2022
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748472
- Sponsor's protocol ID
- Feeding length and oxygenation
- Status last verified
- Apr 2022
- First submitted
- 19 Nov 2018
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants
- ClinicalTrials.gov ID
- NCT03748472
- Acronym / sponsor ID
- Feeding length and oxygenation
- Conditions
- Premature Infant, Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 20 Nov 2018 (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.
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus feeding | Experimental | Procedure: Bolus feeding |
| continuous gavage feeding | Experimental | Procedure: Continuous gavage feeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day
Key exclusion criteria (3 listed)
- Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.
- Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
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 gavage feedingEach subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again. | Procedure or surgery | continuous gavage feeding |
| Bolus feedingEach subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again. | Procedure or surgery | Bolus feeding |
Primary outcome
Oxygenation instability
Time frame: 9 hours (3 feeds)
SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 gavage feeding and Bolus feeding in people with Premature Infant and Respiratory Disease, 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 1 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: finished, as of the sponsor's last update on 28 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation instability (time frame: 9 hours (3 feeds)). 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 28 Apr 2022.