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Human Milk clinical trials

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NCT ID: NCT05959460 Completed - Clinical trials for Exclusive Breastfeeding

Assessing Exclusive Breastfeeding Practice

Start date: January 1, 2016
Phase:
Study type: Observational

This study was a longitudinal design. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo.

NCT ID: NCT03886844 Completed - Weight Gain Clinical Trials

Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Start date: December 2015
Phase:
Study type: Observational

Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth. Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.

NCT ID: NCT03459209 Completed - Human Milk Clinical Trials

Effect of Tube Feeding on LCPUFAs Delivery

Start date: April 1, 2016
Phase:
Study type: Observational

Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA) arachidonic acid (AA) are major building blocks for the lipid bilayer of neuronal and retinal membranes and play a crucial role in brain and visual development. Humans lack enzymes synthetizing DHA and AA precursors and thus rely upon dietary sources to achieve adequate intakes. Human milk (HM) feeding, either own mother's milk (OMM) or donor milk (DM), is the first nutritional choice for preterm infants and provides appropriate LCPUFAs amounts to support neurological and visual development of this fragile population. Due to their immaturity, preterm infants are often unable to coordinate sucking and swallowing, thus requiring tube feeding (TF) for prolonged time periods. During TF, fatty acids tend to separate from aqueous milk components and to adhere to the infusion set, thus reducing the delivery of HM lipid contents. To dare, however, a targeted evaluation of TF-related LCPUFAs losses has not been performed. This study aims to quantitatively assess, by means of gas chromatography coupled to mass spectrometry, the effect of bolus and different continuous feeding methods routinely adopted for preterm infants' enteral nutrition on the delivery of DHA and AA contained in human milk samples.

NCT ID: NCT03001479 Completed - Clinical trials for Premature Birth of Newborn

Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein

Start date: March 13, 2017
Phase: N/A
Study type: Interventional

Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the addition of fortifiers to their milk in order to achieve sufficient levels of calories, vitamins, and minerals for adequate growth. We are currently using a liquid human milk fortifier which does not provide sufficient protein intake, requiring addition of a liquid protein supplement. A new product has been released which provides sufficient protein in the liquid HMF, without the acidification seen in previous products. This is a prospective, randomized noninferiority study comparing the safety and efficacy of the new HMF with additional protein to our current standard of adding additional protein supplementation on top of the HMF.

NCT ID: NCT02133716 Completed - Pain Clinical Trials

Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

LACTEET
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates. This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid. The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose. The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture. The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry. Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

NCT ID: NCT01988792 Completed - Enteral Nutrition Clinical Trials

Human Milk Fortification in Very Low Birth Neonates

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

NCT ID: NCT01932619 Completed - Human Milk Clinical Trials

The Influence of Storage Container and Defrost Process on Components in Breast Milk

Start date: January 2009
Phase: N/A
Study type: Observational

Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.