Very Low Birth Weight InfantVLBWNCT04282655
Effect of Milk Warming on the Very Low Birth Weight Infant
A study testing Treatment Guardian Milk Warmer (Medela TM) in people with Very Low Birth Weight Infant and Weight Gain, run by University of Oklahoma at 1 site in United States.
Trial summary
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal
- What is being tested?
- Treatment Guardian Milk Warmer (Medela TM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2016to 30 Mar 2019
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age 28-32 weeks on full enteral feeding of breast milk
Who cannot join
- Mechanical ventilation
- Positive End Expiratory Pressure (PEEP)
- Total parenteral nutrition, or any congenital anomalies
- Severe to moderate respiratory disease
- Previous medical or surgical necrotizing enterocolitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma, The Children's Hospital
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.
Read the detailed description
The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.
Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.
A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmer™, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.
- Being tested
- Treatment Guardian Milk Warmer (Medela TM), Control
- Keywords
- breast milk, milk warming
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Guardian Milk Warmer (Medela TM)Other
Also called Continuous milk warmer (Guardian Warmer, Medela™)
Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)
ControlOther
Standard warming procedure of breast milk in syringe prior to feeding.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard method of warming breast milk in a hot water bath prior to feeding. Receives: Other: Control |
| Treatment Guardian Milk Warmer (Medela TM) | Experimental | External continuous milk warmer that heats milk within the tubing just posterior to the feeding tube to provide milk at body temperature for feeding infusion. Receives: Other: Treatment Guardian Milk Warmer (Medela TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Comparison of two groups for weight gain over time in grams
Measured: At study completion, 10 days.
Feeding Intolerance
Comparison of feeding tolerance between groups using a residual algorithm
Measured: At study completion, 10 days
Secondary outcomes (2)
Head Circumference
frontal-occipital circumference in centimeters
Measured: At study completion, 10 days
Body Length
Length as measured in centimeters
Measured: At Study completion, 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start2 Sep 2016
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective quasi-experimental controlled trial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris Sekar, MD, Principal investigator, OUHSC Dept of Pediatrics, Neonatal-Perinatal MedicineSusan M Bedwell, DNP, Principal investigator, Univeristy of Oklahoma, The Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282655
- Sponsor's protocol ID
- 6748
- Acronym
- VLBW
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson CA, Berseth CL. Neither motor responses nor gastric emptying vary in response to formula temperature in preterm infants. Biol Neonate. 1996;70(5):265-70. doi: 10.1159/000244375.
PubMed 8955912Blumenthal I, Lealman GT, Shoesmith DR. Effect of feed temperature and phototherapy on gastric emptying in the neonate. Arch Dis Child. 1980 Jul;55(7):562-4. doi: 10.1136/adc.55.7.562.
PubMed 7436507Dumm M, Hamms M, Sutton J, Ryan-Wenger N. NICU breast milk warming practices and the physiological effects of breast milk feeding temperatures on preterm infants. Adv Neonatal Care. 2013 Aug;13(4):279-87. doi: 10.1097/ANC.0b013e31829d8c3a.
PubMed 23912021Eckburg JJ, Bell EF, Rios GR, Wilmoth PK. Effects of formula temperature on postprandial thermogenesis and body temperature of premature infants. J Pediatr. 1987 Oct;111(4):588-92. doi: 10.1016/s0022-3476(87)80127-0.
PubMed 3116191Bedwell SM, Buster B, Sekar K. The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2021 Aug 1;21(4):E86-E92. doi: 10.1097/ANC.0000000000000818.
PubMed 33427754
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT04282655
- Acronym / sponsor ID
- VLBW / 6748
- Keywords
- breast milk, milk warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 25 Feb 2020 (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.
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.
Detailed description
The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.
Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.
A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmer™, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective quasi-experimental controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlStandard method of warming breast milk in a hot water bath prior to feeding. |
| Treatment Guardian Milk Warmer (Medela TM) | Experimental | Other: Treatment Guardian Milk Warmer (Medela TM)External continuous milk warmer that heats milk within the tubing just posterior to the feeding tube to provide milk at body temperature for feeding infusion. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age 28-32 weeks on full enteral feeding of breast milk
Key exclusion criteria (5 listed)
- Mechanical ventilation
- Positive End Expiratory Pressure (PEEP)
- Total parenteral nutrition, or any congenital anomalies
- Severe to moderate respiratory disease
- Previous medical or surgical necrotizing enterocolitis.
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 |
|---|---|---|
| Treatment Guardian Milk Warmer (Medela TM)Also: Continuous milk warmer (Guardian Warmer, Medela™)Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm) | Other | Treatment Guardian Milk Warmer (Medela TM) |
| ControlStandard warming procedure of breast milk in syringe prior to feeding. | Other | Control |
Primary outcome
Weight Gain
Time frame: At study completion, 10 days.
Comparison of two groups for weight gain over time in grams
Feeding Intolerance
Time frame: At study completion, 10 days
Comparison of feeding tolerance between groups using a residual algorithm
2 secondary outcomes
Head Circumference
Time frame: At study completion, 10 days
Body Length
Time frame: At Study completion, 10 days
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 25 Feb 2020.
- Background: PubMed 8955912Anderson CA, Berseth CL. Neither motor responses nor gastric emptying vary in response to formula temperature in preterm infants. Biol Neonate. 1996;70(5):265-70. doi: 10.1159/000244375.
- Background: PubMed 7436507Blumenthal I, Lealman GT, Shoesmith DR. Effect of feed temperature and phototherapy on gastric emptying in the neonate. Arch Dis Child. 1980 Jul;55(7):562-4. doi: 10.1136/adc.55.7.562.
- Background: PubMed 23912021Dumm M, Hamms M, Sutton J, Ryan-Wenger N. NICU breast milk warming practices and the physiological effects of breast milk feeding temperatures on preterm infants. Adv Neonatal Care. 2013 Aug;13(4):279-87. doi: 10.1097/ANC.0b013e31829d8c3a.
- Background: PubMed 3116191Eckburg JJ, Bell EF, Rios GR, Wilmoth PK. Effects of formula temperature on postprandial thermogenesis and body temperature of premature infants. J Pediatr. 1987 Oct;111(4):588-92. doi: 10.1016/s0022-3476(87)80127-0.
- Derived from this study: PubMed 33427754Bedwell SM, Buster B, Sekar K. The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2021 Aug 1;21(4):E86-E92. doi: 10.1097/ANC.0000000000000818.
- 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.
Kris Sekar, MD principal investigator
OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine
Susan M Bedwell, DNP principal investigator
Univeristy of Oklahoma, The Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Guardian Milk Warmer (Medela TM) in people with Very Low Birth Weight Infant and Weight Gain, run by University of Oklahoma 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 1 inclusion and 5 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 25 Feb 2020. 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?
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?
Weight Gain (time frame: At study completion, 10 days.). 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?
On the ClinicalTrials.gov record for NCT04282655, which also lists 5 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 25 Feb 2020.