---
title: Growth and Tolerance of a Partially Hydrolyzed Infant Formula
nct_id: NCT05047978
overall_status: COMPLETED
phase: NA
sponsor: Mead Johnson Nutrition
study_type: INTERVENTIONAL
primary_condition: Growth
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05047978.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05047978"
ct_last_update_post_date: 2024-01-23
last_seen_at: "2026-05-12T07:33:42.384Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Growth and Tolerance of a Partially Hydrolyzed Infant Formula

**Official Title:** Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula

**NCT ID:** [NCT05047978](https://clinicaltrials.gov/study/NCT05047978)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 244
- **Lead Sponsor:** Mead Johnson Nutrition
- **Conditions:** Growth
- **Start Date:** 2021-08-28
- **Completion Date:** 2023-11-21
- **CT.gov Last Update:** 2024-01-23

## Brief Summary

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

## Eligibility

- **Minimum age:** 10 Days
- **Maximum age:** 14 Days
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 10 to 14 days of age at randomization
* singleton birth
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 g (5lbs 8oz or more)
* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and authorization to use and disclose Protected Health information

Exclusion Criteria:

* History of underlying metabolic or chronic disease
* Evidence of feeding difficulties or history of formula intolerance
* Weight at Visit 1 is \<98% of birth weight
* Infant was born large for gestational age from a mother who was diabetic at childbirth
* Infant is immunocompromised
```

## Arms

- **A routine cow's milk-based infant formula** (ACTIVE_COMPARATOR) — A routine cow's milk-based infant formula
- **A partially hydrolyzed cow's milk protein (PHP) infant formula** (EXPERIMENTAL) — A partially hydrolyzed cow's milk protein (PHP) infant formula

## Interventions

- **Cow's milk protein infant formula** (OTHER) — A routine cow's milk-based infant formula
- **Partially hydrolyzed protein infant formula** (OTHER) — A partially hydrolyzed cow's milk protein (PHP) infant formula

## Primary Outcomes

- **Rate of body weight gain** _(time frame: up to 120 days)_

## Secondary Outcomes

- **Body length** _(time frame: up to 365 days of age)_
- **Head circumference** _(time frame: up to 365 days of age)_
- **Growth Z scores** _(time frame: up to 365 days of age)_
- **Growth Z scores** _(time frame: up to 365 days of age)_
- **Growth Z scores** _(time frame: up to 365 days of age)_
- **Recall of study formula intake measured at each study visit** _(time frame: up to 365 days of age)_
- **Recall of stool characteristics measured at each study visit** _(time frame: up to 365 days of age)_
- **Pediatric Quality of Life Family Impact Module** _(time frame: up to 365 days of age)_
- **Pediatric Quality of Life Inventory Infant Scales** _(time frame: 120, 180, 275, and 365 days of age)_
- **Medically confirmed adverse events collected throughout the study period** _(time frame: up to 365 days of age)_
- **Specific medically confirmed adverse events related to gastrointestinal** _(time frame: up to 365 days of age)_
- **Specific medically confirmed adverse events related to allergy** _(time frame: up to 365 days of age)_
- **Body weight** _(time frame: up to 365 days of age)_

## Locations (13)

- Birmingham Pediatric Associates, Birmingham, Alabama, United States
- Southeastern Pediatric Associates, Dothan, Alabama, United States
- Visions Clinical Research-Tucson, Tucson, Arizona, United States
- Northwest Arkansas Pediatric Clinic, Fayetteville, Arkansas, United States
- The Children's Clinic of Jonesboro, Jonesboro, Arkansas, United States
- PAS Research, Tampa, Florida, United States
- Rophe Adult & Pediatric Medicine, Union City, Georgia, United States
- Saltzer Health, Nampa, Idaho, United States
- Springs Medical Research, Owensboro, Kentucky, United States
- Meridian Clinical Research, Grand Island, Nebraska, United States
- The Jackson Clinic, Jackson, Tennessee, United States
- DCOL Center for Clinical Research, Longview, Texas, United States
- PAS Research, McAllen, Texas, United States

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — 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)_
- `outcomes.secondary` — 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.birmingham pediatric associates|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.southeastern pediatric associates|dothan|alabama|united states` — added _(2026-05-12)_
- `locations.visions clinical research-tucson|tucson|arizona|united states` — added _(2026-05-12)_
- `locations.northwest arkansas pediatric clinic|fayetteville|arkansas|united states` — added _(2026-05-12)_
- `locations.the children's clinic of jonesboro|jonesboro|arkansas|united states` — added _(2026-05-12)_
- `locations.pas research|tampa|florida|united states` — added _(2026-05-12)_
- `locations.rophe adult & pediatric medicine|union city|georgia|united states` — added _(2026-05-12)_
- `locations.saltzer health|nampa|idaho|united states` — added _(2026-05-12)_
- `locations.springs medical research|owensboro|kentucky|united states` — added _(2026-05-12)_
- `locations.meridian clinical research|grand island|nebraska|united states` — added _(2026-05-12)_
- `locations.the jackson clinic|jackson|tennessee|united states` — added _(2026-05-12)_
- `locations.dcol center for clinical research|longview|texas|united states` — added _(2026-05-12)_
- `locations.pas research|mcallen|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05047978.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05047978*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*