--- title: Growth of Infants Fed an Extensively Hydrolyzed Infant Formula nct_id: NCT01210391 overall_status: COMPLETED phase: NA sponsor: Société des Produits Nestlé (SPN) study_type: INTERVENTIONAL primary_condition: Growth countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01210391.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01210391" ct_last_update_post_date: 2014-06-26 last_seen_at: "2026-05-12T06:04:59.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Growth of Infants Fed an Extensively Hydrolyzed Infant Formula **Official Title:** Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula. **NCT ID:** [NCT01210391](https://clinicaltrials.gov/study/NCT01210391) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 282 - **Lead Sponsor:** Société des Produits Nestlé (SPN) - **Conditions:** Growth - **Start Date:** 2010-11 - **Completion Date:** 2013-07 - **CT.gov Last Update:** 2014-06-26 ## Brief Summary The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF. ## Eligibility - **Minimum age:** 11 Days - **Maximum age:** 4 Months - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * Healthy newborn singleton infant * Full-term (\>= 37 weeks gestation) * Birth weight between \>= 2500 and \< =4500 g * 14 ± 3 days of age on enrollment * Infant's mother has elected not to breastfeed * baby has been exclusively formula fed a minimum of 3 days prior to enrollment * Study explained and written information provided with Parent/Caregiver * Informed consent signed (parent/legal representative) Exclusion Criteria: * Congenital illness or malformation affecting infant feeding and/or growth * Suspected or known allergy to cow's milk protein * Significant pre-natal and/or post-natal disease * Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment * Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment * Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements * Infant has received probiotics in the seven days prior to enrollment * Infant currently participating in another clinical study * Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol ``` ## Arms - **New hydrolyzed infant formula** (EXPERIMENTAL) — New, extensively hydrolyzed infant formula - **Commercially available infant formula** (ACTIVE_COMPARATOR) — Commercially available, extensively hydrolyzed infant formula. ## Interventions - **Extensively hydrolyzed whey infant formula** (OTHER) — New hydrolyzed infant formula. - **Extensively hydrolyzed casein infant formula** (OTHER) — Commercially available infant formula. ## Primary Outcomes - **Weight Gain** _(time frame: 4 Months)_ — Mean weight gain (g/day) from enrollment to 4 months of age. ## Locations (20) - Colorado Springs Health Partners, Colorado Springs, Colorado, United States - Pedia Research, Newburgh, Indiana, United States - Pedia Research, Owensboro, Kentucky, United States - ARK-LA-Tex Pediatric Research, Bossier City, Louisiana, United States - The Clinical Trials Center, New Orleans, Louisiana, United States - Clinical Research of Nevada, Las Vegas, Nevada, United States - Institute of Clinical Research, Mayfield Heights, Ohio, United States - University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States - Cyn3rgy Research, Gresham, Oregon, United States - Square-1 Clinical Research, Erie, Pennsylvania, United States - Alpha Clinical Research, Clarksville, Tennessee, United States - Jackson Clinic, Jackson, Tennessee, United States - Scott & White Wells Branch Clinic, Austin, Texas, United States - Scott & White Killeen Clinic, Killeen, Texas, United States - DCOL Center for Research, Longview, Texas, United States - Southwest Children's Research Associates, San Antonio, Texas, United States - Scott & White Temple, Temple, Texas, United States - Tanner Clinic, Layton, Utah, United States - Clinical Research Partners, Richmond, Virginia, United States - Wenatchee Valley Medical Center, Wenatchee, Washington, United States ## Recent Field Changes (last 30 days) - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.square-1 clinical research|erie|pennsylvania|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.colorado springs health partners|colorado springs|colorado|united states` — added _(2026-05-12)_ - `locations.pedia research|newburgh|indiana|united states` — added _(2026-05-12)_ - `locations.pedia research|owensboro|kentucky|united states` — added _(2026-05-12)_ - `locations.ark-la-tex pediatric research|bossier city|louisiana|united states` — added _(2026-05-12)_ - `locations.the clinical trials center|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.clinical research of nevada|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.institute of clinical research|mayfield heights|ohio|united states` — added _(2026-05-12)_ - `locations.university of oklahoma health sciences center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.cyn3rgy research|gresham|oregon|united states` — added _(2026-05-12)_ - `locations.alpha clinical research|clarksville|tennessee|united states` — added _(2026-05-12)_ - `locations.jackson clinic|jackson|tennessee|united states` — added _(2026-05-12)_ - `locations.scott & white wells branch clinic|austin|texas|united states` — added _(2026-05-12)_ - `locations.scott & white killeen clinic|killeen|texas|united states` — added _(2026-05-12)_ - `locations.dcol center for research|longview|texas|united states` — added _(2026-05-12)_ - `locations.southwest children's research associates|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.scott & white temple|temple|texas|united states` — added _(2026-05-12)_ - `locations.tanner clinic|layton|utah|united states` — added _(2026-05-12)_ - `locations.clinical research partners|richmond|virginia|united states` — added _(2026-05-12)_ - `locations.wenatchee valley medical center|wenatchee|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01210391.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01210391* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*