Clinical Trials Logo
  1. Home
  2. Preterm Birth
  3. NCT05228535
  4. Details
NCT05228535 Clinical Trial

Human Milk in Preterm Infants

Preterm Birth Clinical Trial

Official title:
Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05228535
Other study ID # 1813934-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2022
Est. completion date December 2023

Study information
Verified date July 2022
Source Augusta University
Contact Zanna Wynter, DO
Phone 770-608-0868
Email zwynter@augusta.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Days
Eligibility Inclusion Criteria: - Birth weight 1000-1500 grams - Admitted to NICU within 24 hours of life - Maternal intent to use human milk Exclusion Criteria: - Congenital anomalies - Feeds not started within the first 96 hours of life - Intrauterine growth restriction

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Human milk fortifier
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds

Locations
Country Name City State
United States Children's Hospital of Georgia Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth velocity weight gain in grams/kg/day at 28 days of life
Secondary Growth velocity weight gain in grams/kg/day at 36 weeks post menstrual age
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04021654 - What is the Future of Vulnerable New-borns