--- title: Evaluation of Human Milk Fortifiers in Preterm Infants nct_id: NCT02307760 overall_status: COMPLETED phase: NA sponsor: Abbott Nutrition study_type: INTERVENTIONAL primary_condition: Infant Growth countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02307760.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02307760" ct_last_update_post_date: 2017-05-11 last_seen_at: "2026-05-12T06:55:17.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Evaluation of Human Milk Fortifiers in Preterm Infants **Official Title:** Evaluation of Two Human Milk Fortifiers in Preterm Infants **NCT ID:** [NCT02307760](https://clinicaltrials.gov/study/NCT02307760) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 164 - **Lead Sponsor:** Abbott Nutrition - **Conditions:** Infant Growth - **Start Date:** 2014-12 - **Completion Date:** 2017-02 - **CT.gov Last Update:** 2017-05-11 ## Brief Summary The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Birth weight of 700 g-1500 g. * ≤ 32 weeks and 0 days GA at birth. * Appropriate for GA (AGA). * Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0). * Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified. * Parent(s) agrees to allow infant to receive both human milk and HMF. * Singleton or twin births only. Exclusion Criteria: * Enteral feeding of preterm infant formula or HMF for \> 7 days. * Expected to be transferred to another facility and will not be able to be followed for at least 15 days. * Serious congenital abnormalities or underlying disease that may affect growth and development. * 5 minute APGAR ≤ 4. * Steroids used at the time of randomization. * Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH). * Mechanical ventilator dependence. * Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy. * Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia). * Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24). * Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment). * Infant has any other condition that, in the opinion of the investigator, precludes participation in the study. * Participation in another study that has not been approved as a concomitant study by AN. ``` ## Arms - **Study Human Milk Fortifier A** (ACTIVE_COMPARATOR) — Acidified processing method. - **Study Human Milk Fortifier B** (EXPERIMENTAL) — Non-acidified processing method. ## Interventions - **Human Milk Fortifier A** (OTHER) — Acidified concentrated liquid human milk fortifier - **Human Milk Fortifier B** (OTHER) — Non-acidified concentrated liquid human milk fortifier ## Primary Outcomes - **Weight Gain** _(time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first))_ — scale measurement g/kg/d ## Secondary Outcomes - **Gastrointestinal Tolerance** _(time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first))_ - **Length** _(time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first))_ - **Head Circumference** _(time frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first))_ ## Locations (18) - University of South Alabama Children's and Women's Hospital, Mobile, Alabama, United States - Banner - University Medical Center Phoenix, Phoenix, Arizona, United States - Yale University, New Haven, Connecticut, United States - Medstar Georgetown University Hospital, Washington D.C., District of Columbia, United States - South Miami Hospital, Miami, Florida, United States - All Children's Hospital / Johns Hopkins, St. Petersburg, Florida, United States - Memorial Hospital of South Bend, South Bend, Indiana, United States - University of Louisville, Louisville, Kentucky, United States - Cohen Children's Medical Center of NY at North Shore, Manhasset, New York, United States - Cohen Children's Medical Center of NY, New Hyde Park, New York, United States - Duke University Medical Center, Durham, North Carolina, United States - MetroHealth Medical Center, Cleveland, Ohio, United States - Lehigh Valley Health Network, Allentown, Pennsylvania, United States - Doctors Hospital at Renaissance/Women's Hospital at Renaissance, Edinburg, Texas, United States - Cook Children's Medical Center, Fort Worth, Texas, United States - Texas Health and Education Institute, Fort Worth, Texas, United States - North Central Baptist Hospital, San Antonio, Texas, United States - Wheaton Franciscan Heathcare Inc.- St. Joseph, Milwaukee, Wisconsin, United States ## Recent Field Changes (last 30 days) - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `locations.university of south alabama children's and women's hospital|mobile|alabama|united states` — added _(2026-05-12)_ - `locations.banner - university medical center phoenix|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.yale university|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.medstar georgetown university hospital|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.south miami hospital|miami|florida|united states` — added _(2026-05-12)_ - `locations.all children's hospital / johns hopkins|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.memorial hospital of south bend|south bend|indiana|united states` — added _(2026-05-12)_ - `locations.university of louisville|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.cohen children's medical center of ny at north shore|manhasset|new york|united states` — added _(2026-05-12)_ - `locations.cohen children's medical center of ny|new hyde park|new york|united states` — added _(2026-05-12)_ - `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.metrohealth medical center|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.lehigh valley health network|allentown|pennsylvania|united states` — added _(2026-05-12)_ - `locations.doctors hospital at renaissance/women's hospital at renaissance|edinburg|texas|united states` — added _(2026-05-12)_ - `locations.cook children's medical center|fort worth|texas|united states` — added _(2026-05-12)_ - `locations.texas health and education institute|fort worth|texas|united states` — added _(2026-05-12)_ - `locations.north central baptist hospital|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.wheaton franciscan heathcare inc.- st. joseph|milwaukee|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02307760.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02307760* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*