PrematurityPrematurityNCT03743207
Preterm Infants May Better Tolerate Warmer Feeds
A study testing Room temperature and Warmer temperature in people with Prematurity and Feeding Disorder Neonatal, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Prematurity, Feeding Disorder Neonatal
- What is being tested?
- Room temperature and Warmer temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2012to 30 Apr 2014
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born to birth weight of ≤1500 g
- Infants born to gestational age of ≤ 34 weeks
Who cannot join
- Genetic syndrome
- Gastrointestinal system anomalies
- Patients born small for their gestational age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.
Read the detailed description
Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.
- Conditions
- Prematurity, Feeding Disorder Neonatal
- Being tested
- Room temperature, Warmer temperature
- Keywords
- Prematurity, Enteral nutrition, Feeding tolerance, Temperature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Room temperatureOther
These infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities.
Warmer temperatureOther
Fifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically.
| Study group | Role | What they receive |
|---|---|---|
| Room temperature | Experimental | All of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature. Receives: Other: Room temperature |
| Warmer temperature | Experimental | The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature. Receives: Other: Warmer temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume in mililitres after every feeding
Gastric residual volume amount during the study
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Transition time to total enteral feeding
The time needed for transition time to total enteral feeding
Measured: through study completion, an average of 6 months
Daily weight gain
The daily weight gain of the infant during the study
Measured: through study completion, an average of 6 months
Need for anti reflux treatment
ıf the infant needed antireflux treatment, the treatment options were recorded
Measured: through study completion, an average of 6 months
Body weight at discharge
Body weight at discharge
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Oct 2012
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Altun Koroglu, Ege University
- Investigators
- Ozge Altun Koroglu, M.D., Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743207
- Sponsor's protocol ID
- EGE20121284
- Acronym
- Prematurity
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 16 Nov 2018
- 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 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03743207
- Acronym / sponsor ID
- Prematurity / EGE20121284
- Conditions
- Prematurity, Feeding Disorder Neonatal
- Keywords
- Prematurity, Enteral nutrition, Feeding tolerance, Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 16 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.
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.
Detailed description
Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room temperature | Experimental | Other: Room temperatureAll of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature. |
| Warmer temperature | Experimental | Other: Warmer temperatureThe investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born to birth weight of ≤1500 g
- Infants born to gestational age of ≤ 34 weeks
Key exclusion criteria (3 listed)
- Genetic syndrome
- Gastrointestinal system anomalies
- Patients born small for their gestational age
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 |
|---|---|---|
| Room temperatureThese infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities. | Other | Room temperature |
| Warmer temperatureFifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically. | Other | Warmer temperature |
Primary outcome
Gastric residual volume in mililitres after every feeding
Time frame: through study completion, an average of 6 months
Gastric residual volume amount during the study
4 secondary outcomes
Transition time to total enteral feeding
Time frame: through study completion, an average of 6 months
Daily weight gain
Time frame: through study completion, an average of 6 months
Need for anti reflux treatment
Time frame: through study completion, an average of 6 months
Body weight at discharge
Time frame: through study completion, an average of 6 months
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 16 Nov 2018.
- 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.
Ozge Altun Koroglu, M.D. study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Room temperature and Warmer temperature in people with Prematurity and Feeding Disorder Neonatal, run by Ege University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 16 Nov 2018. 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 Turkey (Türkiye). 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?
Gastric residual volume in mililitres after every feeding (time frame: through study completion, an average of 6 months). 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 16 Nov 2018.