Effect of Hindmilk on Growth Velocity of Very Preterm Infants

NCT03637413 | Unknown

• 1 other identifier: REB18-0195
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: Does feeding hindmilk improve weight gain in very preterm infants with poor growth velocity? Hypothesis: In very preterm infants (born less than 32 weeks gestation) with poor postnatal growth velocity (\<15 g/kg/day), feeding hindmilk would improve average weight gain by at least 4 g/kg per day. Study design: This will be a prospective cohort study in very preterm infants admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre

Conditions

Weight Gain

Keywords

preterm infants; hindmilk

Outcome Measures

Primary Outcomes (1)

• Average Weight Gain

  Difference in weight gain the week before hindmilk and the week after

  2 weeks

Secondary Outcomes (7)

• Effect of feeding hindmilk on anthropometrics

  At 36 weeks post menstrual age and/or discharge (up to 13 weeks)

• Effect of feeding hindmilk on body mass index

  At 36 weeks post menstrual age and/or discharge (up to 13 weeks)

• Incidence of extra uterine growth restriction

  At 36 weeks post menstrual age and/or discharge (up to 13 weeks)

• Incidence of bronchopulmonary dysplasia and retinopathy of prematurity

  At 36 weeks post menstrual age and/or discharge (up to 13 weeks)

• Correlation between human milk content (fat, protein and energy) and weight gain

  Within 4 weeks of enrollment

Study Arms (1)

Hindmilk

EXPERIMENTAL

Hindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk.

Dietary Supplement: Hindmilk

Interventions

Hindmilk DIETARY_SUPPLEMENT

Mother will be taught to separate her milk and infant will receive only hindmilk for feeds

Hindmilk

Eligibility Criteria

• Age: 2 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Very preterm infant ( \<32 weeks at birth)
• On full enteral feeds for more than 2 weeks (full feed is defined at the time of reaching 120 ml/kg/day with no parenteral nutrition used)
• Poor weight gain (\<15 g/kg per day) despite optimization of energy and protein intakes by RDs (calories intake: 125-135 Kcal/kg per day and protein: 4-4.5 g/kg per day)
• Mothers have enough milk supply (\>150% of infant's daily needs)

You may not qualify if:

• Congenital anomalies
• Small for gestational age infants (\< 10th percentile) at birth

Sponsors & Collaborators

• Belal Alshaikh: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Belal Alshaikh, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belal Alshaikh, MD, MSc

CONTACT

403-955-2320; belal.alshaikh@ahs.ca

Zainab Towage, MD

CONTACT

zainab.towage@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 20, 2018
• Study Start: January 22, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)