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

NCT02716337 | Completed Early Phase 1

• 1 other identifier: Target HM fortification
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postnatal Growth Failure of Preterm Infants; Human Milk Fortification

Keywords

human milk target fortification

Outcome Measures

Primary Outcomes (1)

• Daily growth velocity (g/kg/day)

  From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

Secondary Outcomes (3)

• weekly weight increase (g/week)

  From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

• weekly length increase (cm/week)

  From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

• head circumference increase (cm/week)

  From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

Other Outcomes (1)

• osmolality of fortified human milk

  From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)

Study Arms (1)

Intervention group

OTHER

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

Interventions

Addition of human milk fortifiers according to human milk analysis DIETARY_SUPPLEMENT

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Related Publications (1)

• Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.

  PMID: 27370649 DERIVED

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 23, 2016
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share