Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants

Prematurity Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420531
• Other study ID #: IRB-300013026
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Est. completion date: May 2030

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Ariel A. Salas, MD, MSPH
• Phone: 205-934-4680
• Email: asalas[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Description:

Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.

Participants will:

• Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age

• Have four body composition assessments with a bioelectrical impedance analyzer throughout study period

• Have four stool samples collected throughout study period

• Have four maternal breastmilk samples collected and analyzed throughout the study period

• Have one blood sample collected at 36 weeks corrected age

• Have the option to participate in a follow-up survey completed by parents at 2-3 years of age

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 486
• Est. completion date: May 2030
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Hours to 4 Days

Eligibility

Inclusion Criteria:

• Gestational age between 27 0/7 and 31 6/7 weeks

• Birthweight of 1500 grams or less

• Human milk feeding during the first 14 days after birth

• Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth

Exclusion Criteria:

• Necrotizing enterocolitis stage 2 or greater

• Spontaneous intestinal perforation

• Major congenital/chromosomal anomalies

• Terminal illness requiring limited or withheld support

• Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)

• Any formula feeding within the first 14 days after birth

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Biological:
• Human milk
maternal breastmilk or donor breastmilk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Intestinal Microbiome	Determined by molecular analyses of fecal samples	Birth to 36 weeks postmenstrual age
Other	Changes in Metabolic Pathways	Determined by molecular analyses of serum samples	36 weeks postmenstrual age or discharge (whichever occurs first)
Other	Cognitive scores	Neurodevelopmental outcomes measured by voluntary PARCA-R survey	2 - 3 years of age
Primary	Fat-free Mass (FFM)-For-age-Z-score	Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	Body fat percentage	Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	Birth to 36 weeks postmenstrual age
Secondary	Anthropometric Measurements	Weight, length, and head circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).	Birth to 36 weeks postmenstrual age
Secondary	Bronchopulmonary Dysplasia	Number of participants receiving supplemental oxygen at 36 weeks (PMA)	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	Number of Days Alive and Receiving Full Enteral Feeding	Time to full enteral feeding days	Birth to 28 days
Secondary	Duration of Hospital Stay in Days	From day of admission to day of hospital discharge to home	Birth to 120 days or discharge, whichever occurs first
Secondary	Growth Rate	Weight gain in g/kg/day	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
Secondary	Number of Participants with Postnatal Faltering Growth	Diagnosis of faltering growth (weight z score decline from birth to 36 weeks > 1) using the 2013 Fenton growth curve.	36 weeks or hospital discharge (whichever occurs first)
Secondary	Number of Participants diagnosed with Necrotizing Enterocolitis	Diagnosis of necrotizing enterocolitis stage 2 or 3	From birth up to 120 days following birth
Secondary	Number of Participants with Diagnosis of Intestinal Perforation	Diagnosis of intestinal perforation	From birth up to 120 days following birth
Secondary	Death	Death prior to 121 days of life	Birth to 120 days
Secondary	Culture-proven Sepsis	Diagnosis of sepsis with positive blood cultures	Birth to 120 days
Secondary	Fat Mass (FM)- For age Z-score	Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	Body Fat (BF)-For age Z-score	Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer