Clinical Trials Logo

Clinical Trial Summary

Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.


Clinical Trial Description

1. Study design This is an interventional, randomized, controlled study. 2. Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book. Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life. Fortification will be done according to the randomization group. 3. Outline of the study design - Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer. - In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL - Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation. - Growth speed calculation: Weight gain: (1000x ln [Final weight / Initial weight]) / number of days. 4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04982133
Study type Interventional
Source Hospital Universitario La Paz
Contact
Status Completed
Phase N/A
Start date April 19, 2021
Completion date April 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06105333 - Fidgety Movements of Preterm Neonates Included in COSGOD III
Recruiting NCT05729321 - Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Completed NCT05509621 - The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation N/A
Enrolling by invitation NCT06116747 - The SUPPORTED Study - First-time Fathers of Preterm Infants. N/A
Active, not recruiting NCT01443195 - Iron Metabolism in Small Pre Term Newborns N/A
Withdrawn NCT05053269 - Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Not yet recruiting NCT06118801 - The Effect of Probiotics Added to the Mother's Diet on Preterm Babies N/A
Completed NCT05453734 - The Effect of Progressive Muscle Relaxation Exercises N/A
Recruiting NCT05230199 - Sensory Optimization of the Hospital Environment N/A
Completed NCT06204146 - The Effect of Massage on Growth And Stress And Stress ,Department of Nursing, N/A
Recruiting NCT05687500 - Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP) Phase 2
Completed NCT05830955 - The Effect of Lullaby and Breastmilk Smell on Preterm Newborns N/A
Active, not recruiting NCT06246032 - Impact of Modified Feeding Protocol on Neonatal Outcomes N/A
Not yet recruiting NCT05331235 - Blood Transfusions in Preterm Infants
Completed NCT05359809 - Peripheral Intravenous Central Catheter Intervention in Preterm Infants N/A
Not yet recruiting NCT05434364 - Comparison Three Methods on Endotracheal Aspiration in Preterm Infants N/A
Completed NCT05805254 - Neurofunctional Study of Preterm Infants' Brain Activity
Completed NCT01776281 - Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants Phase 2
Completed NCT05978674 - The Effect of Rocking Bed on Preterm Newborns N/A
Completed NCT05261503 - Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants N/A