## Protocol Section
### Identification Module
**NCT ID:** NCT06420531

**Brief Title:** Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants

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

#### Organization Study ID Info
**ID:** IRB-300013026
#### Organization
**Class:** OTHER
**Full Name:** University of Alabama at Birmingham
### Status Module
#### Completion Date
**Date:** 2030-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-04

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alabama at Birmingham

#### Responsible Party

**Investigator Affiliation:** University of Alabama at Birmingham

**Investigator Full Name:** Ariel A. Salas

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**Detailed 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

### Conditions Module

**Conditions:**

- Prematurity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel Assignment

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 486

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.

**Intervention Names:**

- Biological: Human milk

**Label:** Intervention: 180-200 mL/kg/day of human milk

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.

**Intervention Names:**

- Biological: Human milk

**Label:** Control:140-160 mL/kg/day of human milk

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control:140-160 mL/kg/day of human milk

- Intervention: 180-200 mL/kg/day of human milk

**Description:** maternal breastmilk or donor breastmilk

**Name:** Human milk

**Type:** BIOLOGICAL

### Outcomes Module

#### Other Outcomes

**Description:** Determined by molecular analyses of fecal samples

**Measure:** Changes in Intestinal Microbiome

**Time Frame:** Birth to 36 weeks postmenstrual age

**Description:** Determined by molecular analyses of serum samples

**Measure:** Changes in Metabolic Pathways

**Time Frame:** 36 weeks postmenstrual age or discharge (whichever occurs first)

**Description:** Neurodevelopmental outcomes measured by voluntary PARCA-R survey

**Measure:** Cognitive scores

**Time Frame:** 2 - 3 years of age

#### Primary Outcomes

**Description:** 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

**Measure:** Fat-free Mass (FFM)-For-age-Z-score

**Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

#### Secondary Outcomes

**Description:** 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.

**Measure:** Body fat percentage

**Time Frame:** Birth to 36 weeks postmenstrual age

**Description:** Weight, length, and head circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).

**Measure:** Anthropometric Measurements

**Time Frame:** Birth to 36 weeks postmenstrual age

**Description:** Number of participants receiving supplemental oxygen at 36 weeks (PMA)

**Measure:** Bronchopulmonary Dysplasia

**Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

**Description:** Time to full enteral feeding days

**Measure:** Number of Days Alive and Receiving Full Enteral Feeding

**Time Frame:** Birth to 28 days

**Description:** From day of admission to day of hospital discharge to home

**Measure:** Duration of Hospital Stay in Days

**Time Frame:** Birth to 120 days or discharge, whichever occurs first

**Description:** Weight gain in g/kg/day

**Measure:** Growth Rate

**Time Frame:** Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).

**Description:** Diagnosis of faltering growth (weight z score decline from birth to 36 weeks \> 1) using the 2013 Fenton growth curve.

**Measure:** Number of Participants with Postnatal Faltering Growth

**Time Frame:** 36 weeks or hospital discharge (whichever occurs first)

**Description:** Diagnosis of necrotizing enterocolitis stage 2 or 3

**Measure:** Number of Participants diagnosed with Necrotizing Enterocolitis

**Time Frame:** From birth up to 120 days following birth

**Description:** Diagnosis of intestinal perforation

**Measure:** Number of Participants with Diagnosis of Intestinal Perforation

**Time Frame:** From birth up to 120 days following birth

**Description:** Death prior to 121 days of life

**Measure:** Death

**Time Frame:** Birth to 120 days

**Description:** Diagnosis of sepsis with positive blood cultures

**Measure:** Culture-proven Sepsis

**Time Frame:** Birth to 120 days

**Description:** 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.

**Measure:** Fat Mass (FM)- For age Z-score

**Time Frame:** 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer

**Description:** 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.

**Measure:** Body Fat (BF)-For age Z-score

**Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 4 Days

**Minimum Age:** 6 Hours

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** asalas@uab.edu

**Name:** Ariel A. Salas, MD, MSPH

**Phone:** 205-934-4680

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** UAB Hospital

**Name:** Ariel A. Salas, MD, MSPH

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Prematurity

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-31
