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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03501485
Other study ID # 0741-16-TLV-DM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 18, 2017
Est. completion date February 1, 2022

Study information

Verified date July 2019
Source Tel-Aviv Sourasky Medical Center
Contact Dror Mandel, MD
Phone +97236925690
Email drorm@tlvmc.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Ventilated infant (invasive or non-invasive)

- Necrotizing enterocolitis (NEC)

- IVH grade 3-4

- BPD

- PDA

- Active infection.

- Congenital or genetic disorder ( trisomy, heart defect.)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Department of Neonatology Tel Aviv Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At day 0, 2, 3, 4
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