Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716337
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.

Condition or disease Intervention/treatment Phase
Postnatal Growth Failure of Preterm Infants Human Milk Fortification Dietary Supplement: Addition of human milk fortifiers according to human milk analysis Early Phase 1

Detailed Description:
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Fortified human milk is the goal for preterm infants' nutrition. Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk. Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk. Osmolality, metabolic and gastrointestinal tolerance were monitored.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : October 2014
Actual Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Intervention group
In the intervention group VLBW infants were fed target fortified human milk Growth and safety were compared to a historical group of VLBW infants fed with standard fortified human milk
Dietary Supplement: Addition of human milk fortifiers according to human milk analysis



Primary Outcome Measures :
  1. Daily growth velocity (g/kg/day) [ Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) ]

Secondary Outcome Measures :
  1. weekly weight increase (g/week) [ Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) ]
  2. weekly length increase (cm/week) [ Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) ]
  3. head circumference increase (cm/week) [ Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) ]

Other Outcome Measures:
  1. osmolality of fortified human milk [ Time Frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Birth weight < 1500 grams
  • Gestational age < 32 weeks
  • Birth weight > 10th percentile according to Fenton' growth chart
  • Exclusively breast feeding during the entire hospital stay

Exclusion criteria:

- Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Pier Mannuccio Mannucci, PHD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02716337     History of Changes
Other Study ID Numbers: Target HM fortification
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
human milk target fortification
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Failure to Thrive
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Signs and Symptoms