Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

• Sponsor: ByHeart (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04389606
• Collaborator: Paidion Research, Inc. (Industry)
• Enrollment: 311
• Locations: 27
• Arms: 3
• Actual Duration (Months): 13
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Term Infants	Other: Study Formula (SF); Other: Comparator Formula (CF)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
• Actual Study Start Date: May 12, 2020
• Actual Primary Completion Date: Jun 11, 2021
• Actual Study Completion Date: Jun 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Formula (SF) New infant formula for term infants	Other: Study Formula (SF); New infant formula for term infants fed ad lib; Other: Comparator Formula (CF); Commercially available infant formula for term infants fed ad lib
Active Comparator: Comparator Formula (CF) Commercially available infant formula for term infants	Other: Study Formula (SF); New infant formula for term infants fed ad lib; Other: Comparator Formula (CF); Commercially available infant formula for term infants fed ad lib
No Intervention: Human Milk Reference Group Human milk

Outcome Measures

Primary Outcome Measures

1. Weight Gain Velocity [up to 24 weeks]

   G/D

Secondary Outcome Measures

1. Weight Measures [20 weeks, 24 weeks]

   KG

2. Length Measures [20 weeks, 24 weeks]

   CM

3. Length Gain Velocity [20 weeks, 24 weeks]

   CM/D

4. Head Circumference Measures [20 weeks, 24 weeks]

   CM

5. Weight for age Z-scores [20 weeks, 24 weeks]

   Weight for age Z-scores compared to World Health Organization (WHO) growth standards

6. Length for age Z-scores [20 weeks, 24 weeks]

   Length for age Z-scores compared to WHO growth standards

7. Head circumference for age Z-scores [20 weeks, 24 weeks]

   Head circumference for age Z-scores compared to WHO growth standards

8. Weight for length Z-scores [20 weeks, 24 weeks]

   Weight for length Z-scores compared to WHO growth standards

9. 72-hr record of formula intake at each study visit [20 weeks, 24 weeks]

   oz/d

10. Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) [24 weeks]

    Concentration

11. Blood concentrations of amino acids (umol/L) [24 weeks]

    Concentration

12. Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals [24 weeks]

    Concentration

13. Medically-diagnosed adverse events collected throughout the study period [16-24 weeks]

    Frequency

14. Parent rating of infant stool consistency at each study visit [20 weeks, 24 weeks]

    Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]).

15. Parent report of infant stool frequency at each study visit [20 weeks, 24 weeks]

    Mean

16. Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit [20 weeks, 24 weeks]

    Mean

17. Stool microbiome [24 weeks]

    Fecal microbial taxa and community abundance

18. Stool metabolome [24 weeks]

    Targeted and Untargeted Metabolomics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Weeks to 19 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion Criteria:

• Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics	Birmingham	Alabama	United States	35126
2	Watching Over Mothers and Babies	Tucson	Arizona	United States	85712
3	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas	United States	72401
4	Applied Research Center of Arkansas	Little Rock	Arkansas	United States	72212
5	San Gabriel Women's Health	Arcadia	California	United States	91007
6	Northern California Research	Sacramento	California	United States	95812
7	Optum	Colorado Springs	Colorado	United States	80922
8	Topaz Clinical Research	Apopka	Florida	United States	32703
9	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
10	Avanza Medical Research	Pensacola	Florida	United States	32503
11	PAS-Research	Tampa	Florida	United States	33613
12	Clinical Research Prime	Idaho Falls	Idaho	United States	83404
13	Southern Clinical Research	Zachary	Louisiana	United States	70791
14	Sierra Clinical Research	Las Vegas	Nevada	United States	89106
15	Pediatric Associates of Mt. Carmel, Inc	Cincinnati	Ohio	United States	45245
16	Schear Family Practice	Dayton	Ohio	United States	45406
17	Pediatric Associates of Fairfield, Inc.	Fairfield	Ohio	United States	45014
18	Institute of Clinical Research	Mentor	Ohio	United States	44060
19	Coastal Pediatric Research	Charleston	South Carolina	United States	29414
20	Coastal Pediatric Associates	Summerville	South Carolina	United States	29486
21	HMG Primary Care at Sapling Grove	Bristol	Tennessee	United States	37620
22	Jackson Clinic North	Jackson	Tennessee	United States	38305
23	HMG Pediatrics at Kingsport	Kingsport	Tennessee	United States	37660
24	Houston Clinical Research Associates	Houston	Texas	United States	77090
25	DCOL Center for Clinical Research	Longview	Texas	United States	75165
26	ACRC Trials Plano Pediatrics	Plano	Texas	United States	75093
27	Tanner Clinic	Layton	Utah	United States	84041

Sponsors and Collaborators

• ByHeart
• Paidion Research, Inc.

Investigators

• Study Director: Devon Kuehn, MD, ByHeart, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ByHeart
• ClinicalTrials.gov Identifier: NCT04389606
• Other Study ID Numbers: SS-101-Follow-up
• First Posted: May 15, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ByHeart: Infant; Infant Formula; Healthy Subjects

Study Results

No Results Posted as of Jul 21, 2021