Infant,PrematureNCT03501485
Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.
An observational study of Infant,Premature, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a 24 hour period by the body during resting conditions. It is closely related to, but not identical to, basal metabolic rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant,Premature
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Dec 2017to 1 Feb 2022
- Phase
- Observational
- 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
Study population: Healthy, appropriate weight for gestational age, gavage-fed, preterm infants
Who may be able to join
- Preterm infants born with birth weight < 1500 g gestation
- Full enteral feeds (150-160 ml/kg/d) of breast milk fortified with standard HM fortifier will be well tolerated for 2 days, without significantly gastric residuals (less than 5%)
- Clinically and thermally stable.
Who cannot join
- Ventilated infant (invasive or non-invasive)
- Necrotizing enterocolitis (NEC)
- IVH grade 3-4
- BPD
- PDA
- Active infection.
- Congenital or genetic disorder ( trisomy, heart defect.)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Neonatology Tel Aviv Medical Center
Tel Aviv, 64239
Dror Mandel, MD, +97236925690, drorm@tlvmc.gov.il
About this study
Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a 24 hour period by the body during resting conditions. It is closely related to, but not identical to, basal metabolic rate.
According to the ESPGHAN committee guidelines on enteral nutrient supply for preterm infants, which were published in 2010, the daily protein intake of extremely low birth weight infants shall be 4.5 g/kg/day, and for those above 1000g, 4 g/kg/day. In order to meet these recommendations, the human milk for all premature infants is enriched with human milk fortifier, and supplemental liquid protein according to our NICU protocol.
Read more
Little is known on the effect of this enrichment on the basal metabolic rate of premature infants.
One way of determining the basal metabolic rate is by measuring the resting energy expenditure. In order to do that the investigators use an indirect calorimety by using the Deltatrac II metabolic monitor (Datex-Ohmeda). This instrument uses the principle of the open-circuit system that allows continuous measurements of oxygen consumption and carbon dioxide production using a constant flow generator.
Read the detailed description
Infants will be enrolled when tolerating full feeds (150-160 ml/kg/d) of human breast milk fortified with standard fortifier for 2 days and before protein supplementation.
Metabolic studies will be conducted while the infants are prone and asleep and at the same time of the day (noon time) for all infants, starting 1 hour after the completion of the last feed. Measurements will be stopped during body movements.
Each measure, once a day, will last for 30 min. A total of 4 REE measurements will be performed for all participants: before starting with protein supplementation, on day 0 (D0), and at days 2, 3 and 4 of protein supplementation.
- Conditions
- Infant,Premature
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic measurements
Changes in metabolic measurements through indirect calorimetry using using a Deltatrac II metabolic monitor from baseline at day 0, throughout day 2, 3 and 4.
Measured: At day 0, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start18 Dec 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror Mandel, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501485
- Sponsor's protocol ID
- 0741-16-TLV-DM
- Status last verified
- Jul 2019
- First submitted
- 6 Feb 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.
- ClinicalTrials.gov ID
- NCT03501485
- Acronym / sponsor ID
- 0741-16-TLV-DM
- Conditions
- Infant,Premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 18 Apr 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.
Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a 24 hour period by the body during resting conditions. It is closely related to, but not identical to, basal metabolic rate.
According to the ESPGHAN committee guidelines on enteral nutrient supply for preterm infants, which were published in 2010, the daily protein intake of extremely low birth weight infants shall be 4.5 g/kg/day, and for those above 1000g, 4 g/kg/day. In order to meet these recommendations, the human milk for all premature infants is enriched with human milk fortifier, and supplemental liquid protein according to our NICU protocol.
Little is known on the effect of this enrichment on the basal metabolic rate of premature infants.
One way of determining the basal metabolic rate is by measuring the resting energy expenditure. In order to do that the investigators use an indirect calorimety by using the Deltatrac II metabolic monitor (Datex-Ohmeda). This instrument uses the principle of the open-circuit system that allows continuous measurements of oxygen consumption and carbon dioxide production using a constant flow generator.
Detailed description
Infants will be enrolled when tolerating full feeds (150-160 ml/kg/d) of human breast milk fortified with standard fortifier for 2 days and before protein supplementation.
Metabolic studies will be conducted while the infants are prone and asleep and at the same time of the day (noon time) for all infants, starting 1 hour after the completion of the last feed. Measurements will be stopped during body movements.
Each measure, once a day, will last for 30 min. A total of 4 REE measurements will be performed for all participants: before starting with protein supplementation, on day 0 (D0), and at days 2, 3 and 4 of protein supplementation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy, appropriate weight for gestational age, gavage-fed, preterm infants
Key inclusion criteria (3 listed)
- Preterm infants born with birth weight < 1500 g gestation
- Full enteral feeds (150-160 ml/kg/d) of breast milk fortified with standard HM fortifier will be well tolerated for 2 days, without significantly gastric residuals (less than 5%)
- Clinically and thermally stable.
Key exclusion criteria (7 listed)
- Ventilated infant (invasive or non-invasive)
- Necrotizing enterocolitis (NEC)
- IVH grade 3-4
- BPD
- PDA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in metabolic measurements
Time frame: At day 0, 2, 3, 4
Changes in metabolic measurements through indirect calorimetry using using a Deltatrac II metabolic monitor from baseline at day 0, throughout day 2, 3 and 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
Dror Mandel, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant,Premature, run by Tel-Aviv Sourasky Medical Center 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 3 inclusion and 7 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 16 Jun 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 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 Dror Mandel, MD (+97236925690, drorm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metabolic measurements (time frame: At day 0, 2, 3, 4). 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 Jun 2020.