Clinical trial NCT02716337: Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postnatal Growth Failure of Preterm Infants
Human Milk Fortification
Keywords: human milk target fortification
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Daily growth velocity (g/kg/day)
timeFrame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Secondary outcomes:
measure: weekly weight increase (g/week)
timeFrame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
measure: weekly length increase (cm/week)
timeFrame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
measure: head circumference increase (cm/week)
timeFrame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Other outcomes:
measure: osmolality of fortified human milk
timeFrame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Locations:
Study officials:
References:
citation: 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.