Enteral FeedingNCT02034903
Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation
A study testing Feedings warmed with commercial warmer in people with Enteral Feeding, run by Advocate Center for Pediatric Research at 1 site in United States.
Trial summary
The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- Feedings warmed with commercial warmer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2015
- 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 born at less than or equal to 30 0/7 weeks gestation
- Infants will be enrolled within the first 48 hours of life
Who cannot join
- Gastrointestinal anomalies
- Lethal malformations
- Parental denial of consent or request for removal from study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Advocate Children's Hospital, Park Ridge
Park Ridge, Illinois, 60068
Jeanne Wiesbrock, MS, 847-723-7046, jeanne.wiesbrock@advocatehealth.com
Bonnie Satinover, BSN
About this study
The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.
- Conditions
- Enteral Feeding
- Being tested
- Feedings warmed with commercial warmer
- Keywords
- Enteral Feeding, Infant, Premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedings warmed with commercial warmerOther
| Study group | Role | What they receive |
|---|---|---|
| Standard warming | No intervention | Feeding warmed in water bath |
| Commercial warmer | Experimental | Feedings warmed with a commercial warmer Receives: Other: Feedings warmed with commercial warmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding intolerance
Feeding intolerance is defined by one or more of the following clinical observations:
- Abdominal distention defined as increase in abdominal girth > 1 cm. since previous nursing assessment
- Obvious blood in stool
- Persistent regurgitation (>3 consecutive feedings)
- Significant gastric residuals:
- 25-50% of feeding volume x 2 consecutive feeds
- > 50% of feeding volume x 1 feed
Measured: 168 completed feedings; approximately 28 days
Secondary outcomes (1)
Full enteral feeding
The point in time that parenteral nutrition is discontinued based on the judgment that the infant's enteral intake is sufficient to continue growth and development.
Measured: approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advocate Center for Pediatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Medela AG
- Responsible party
- Principal investigator, Bonnie Satinover, Advocate Center for Pediatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034903
- Sponsor's protocol ID
- 5283
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2014
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation
- ClinicalTrials.gov ID
- NCT02034903
- Acronym / sponsor ID
- 5283
- Conditions
- Enteral Feeding
- Keywords
- Enteral Feeding, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Advocate Center for Pediatric ResearchUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Medela AG
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 14 Jan 2014 (estimated)
- 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.
The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard warming | No intervention | –Feeding warmed in water bath |
| Commercial warmer | Experimental | Other: Feedings warmed with commercial warmerFeedings warmed with a commercial warmer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Preterm infants born at less than or equal to 30 0/7 weeks gestation
- Infants will be enrolled within the first 48 hours of life
Key exclusion criteria (3 listed)
- Gastrointestinal anomalies
- Lethal malformations
- Parental denial of consent or request for removal from study
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 |
|---|---|---|
| Feedings warmed with commercial warmer | Other | Commercial warmer |
Primary outcome
Feeding intolerance
Time frame: 168 completed feedings; approximately 28 days
Feeding intolerance is defined by one or more of the following clinical observations: 1. Abdominal distention defined as increase in abdominal girth > 1 cm. since previous nursing assessment 2. Obvious blood in stool 3. Persistent regurgitation (>3 consecutive feedings) 4. Significant gastric residuals: 1. 25-50% of feeding volume x 2 consecutive feeds 2. > 50% of feeding volume x 1 feed
1 secondary outcome
Full enteral feeding
Time frame: approximately 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedings warmed with commercial warmer in people with Enteral Feeding, run by Advocate Center for Pediatric Research 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 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 14 Jan 2014. 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 Bonnie Satinover, BSN (847-723-5386, bonnie.satinover@advocatehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding intolerance (time frame: 168 completed feedings; approximately 28 days). 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 14 Jan 2014.