Infant,Premature Clinical Trial
Official title:
Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03445689 -
Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
|
||
Completed |
NCT03245723 -
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)
|
N/A | |
Active, not recruiting |
NCT03575897 -
Serial Assessment of Body Fat Accrual in Very Preterm Infants
|
N/A | |
Completed |
NCT03082313 -
Movement-based Infant Intervention
|
N/A | |
Completed |
NCT03696758 -
Improving Right Ventricular Function in Young Adults Born Preterm
|
Phase 2 | |
Withdrawn |
NCT01569633 -
Use of Prokinetics in Early Enteral Feeding in Preterm Infants
|
N/A | |
Terminated |
NCT03532555 -
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
|
N/A | |
Completed |
NCT03230032 -
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
|
N/A | |
Recruiting |
NCT03693287 -
Personalized vs Standardized PN for Preterm Infants >1250g
|
Phase 4 | |
Terminated |
NCT03542812 -
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
|
Early Phase 1 | |
Completed |
NCT03434743 -
Non-nutritive Sucking and Breastfeeding in Preterm Infants
|
N/A | |
Active, not recruiting |
NCT03168516 -
Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
|
Phase 3 | |
Completed |
NCT03357458 -
Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age
|
N/A | |
Recruiting |
NCT03521063 -
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
|
Phase 4 | |
Recruiting |
NCT06416956 -
Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
|
||
Completed |
NCT03280381 -
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
|
N/A | |
Completed |
NCT03586856 -
Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment
|
N/A | |
Completed |
NCT03333174 -
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
|
N/A | |
Completed |
NCT03333161 -
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
|
N/A | |
Active, not recruiting |
NCT03558737 -
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
|
N/A |