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NCT05104073Completed

Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Source: ClinicalTrials.gov · Last updated 21 May 2025

Brief summary (registry, in English)

The purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or more.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
11 Oct 2021
Start date
20 Jan 2022
Primary completion date
30 May 2024
Lead sponsor
Milton S. Hershey Medical Center
Diseases
Obesity
NCT number
NCT05104073

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 20 Jan 2022 to the primary completion date, 30 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Infants who weigh less than their birthweight 21 days after delivery

Who the study is looking for

  • Term or Early Term (≥37 weeks), singleton infants
  • Infant birthweight ≥50th percentile based on the 2013 Fenton Growth Charts (which account for sex of child and gestational age at birth)
  • Infant without substantial neonatal morbidity that would affect feeding or weight gain (e.g. known chromosomal abnormality, metabolic disorder, cleft lip/palate, etc.)
  • Infant age ≤1 month
  • Mothers with pre-pregnancy body mass index ≥25 kg/m2
  • Mothers ≥18 years old
  • Parental plan to exclusively feed infant 19-20 kcal/ounce formula upon delivery or by the start of the intervention period \~1 month after delivery
  • Parental intention to have infant well child visits through age 6 months at a Division of Academic General Pediatrics practice site (Hope Drive, Elizabethtown, Nyes Road)
  • English speaking parent

Age in the registry: 1 day to 1 month · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Penn State Milton S. Hershey Medical Center
Coordinator of this site? Confirm its status
HersheyUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.