Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.

NCT03501485 | Unknown

• 1 other identifier: 0741-16-TLV-DM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant,Premature

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, appropriate weight for gestational age, gavage-fed, preterm infants

You may qualify if:

• 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.

You may not qualify if:

• Ventilated infant (invasive or non-invasive)
• Necrotizing enterocolitis (NEC)
• IVH grade 3-4
• BPD
• PDA
• Active infection.
• Congenital or genetic disorder ( trisomy, heart defect.)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Neonatology Tel Aviv Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dror Mandel, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Mandel, MD

CONTACT

+97236925690; drorm@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: April 18, 2018
• Study Start: December 18, 2017
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: June 16, 2020

Record last verified: 2019-07

Locations

IL (1)