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Effect of Hindmilk on Growth Velocity of Very Preterm Infants

Primary Purpose

Weight Gain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hindmilk
Sponsored by
Belal Alshaikh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain focused on measuring preterm infants, hindmilk

Eligibility Criteria

2 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria

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

Sites / Locations

  • Foothills Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hindmilk

Arm Description

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

Outcomes

Primary Outcome Measures

Average Weight Gain
Difference in weight gain the week before hindmilk and the week after

Secondary Outcome Measures

Effect of feeding hindmilk on anthropometrics
Compared to published rates in NICUs
Effect of feeding hindmilk on body mass index
Compared to published rates in NICUs
Incidence of extra uterine growth restriction
Defined as wight less than 10th percentile. Compared to published rates in NICUs
Incidence of bronchopulmonary dysplasia and retinopathy of prematurity
BPD will be defined according to Child Health and Human Development as the requirement for positive pressure support (CPAP or high flow nasal cannula ≥ 1 liter per minute (LPM)), or oxygen dependency at 36 corrected gestational age. ROP will be defined according to the international classification1 or requiring treatment. Compared to published rates in NICUs
Correlation between human milk content (fat, protein and energy) and weight gain
Linear regression analysis will be used to correct for any confounding factors
Effect of hindmilk on erythrocyte membranes fatty acids profile.
Comparison between sample taken at 24 hours and sample at week 2-4 after hindmilk
Changes in mother's milk volumes after feeding hindmilk.
Monitor the milk output of mothers throughout the study

Full Information

First Posted
August 14, 2018
Last Updated
November 4, 2022
Sponsor
Belal Alshaikh
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1. Study Identification

Unique Protocol Identification Number
NCT03637413
Brief Title
Effect of Hindmilk on Growth Velocity of Very Preterm Infants
Official Title
Effect of Hindmilk on Growth Velocity of Very Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Belal Alshaikh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Extra-uterine growth restriction (EUGR) is one of the most common findings among very preterm infants at discharge from neonatal intensive care units. EUGR is associated with major morbidities such as bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) and impaired neurodevelopment. EUGR is caused by slow postnatal growth and largely results from energy and protein deficits. These deficits occur despite the current fortifications of human milk. Hindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk. Feeding hindmilk can be a natural and innovative way to provide additional calories for very preterm infant. Hindmilk is rich in some fatty acids that are currently under investigation to prevent BPD and ROP and improve neurodevelopment. The aim of this study is to assess growth benefits of feeding hindmilk and to explore whether it can improve fatty acids profile in very preterm infants. Dietitians (RD) and Lactation Consultant (LC) will screen and identify eligible mother-infant pairs. Once mother's consent obtained, LC will hand out the "hindmilk information sheet" and teach the mother how to separate her milk. A sample (10 ml) of composite pumped fresh milk will be collected and placed in the fridge. These samples will be sent for analysis within 24 hours of collection to minimize any changes to contents. Samples for Erythrocyte membrane fatty acid (FA) profile will be collected on dried blood spot (30-100 µL). These samples will be collected within 72 hours of the consent. It will be coordinated with blood tests ordered by the clinical team within that period. Dried blood spots are stable in room temperature for 28 days however we will store them in the -80̊ C freezer within 72 hours of collection. Another milk sample, hindmilk this time, will be sent for testing within 24-48 hour of starting hindmilk. This is to ensure that assessment of milk contents is performed in the same mother's lactation stage. The second dried blood spot will be drawn after 2-4 weeks of starting hindmilk. The 2-4 weeks period is to allow timing with other blood work-ups. In General, blood glucose is done every 2-3 days in babies with poor growth and growth laboratory testing is normally done every 2-3 weeks. Data on fluid volumes, feeds, macronutrients intakes and any change in nutrition plan will be collected from electronic dietitian's notes. Dietitians will ensure proper and detailed documentation of nutritional information. Average weight gain (in gram/kg per day) is calculated as mentioned before. Average weight gain will be compared initially between the week before and the week after starting hindmilk. The day that hindmilk started will be used to identify the start point however it will not be used in either the pre- or the post-hindmilk calculation. Clinical team will be encouraged to not order other changes to the nutrition plan for the first week after starting hindmilk. Daily weight, weekly length and head circumference will be collected from the electronic charts. Furthermore, weight, length and head circumference at completed gestational week will be used to calculate Z scores using Fenton Z scores calculator. Data on maternal and neonatal characteristics will be collected from their electronic and physical charts. Composite milk, foremilk and hindmilk volumes will be collected from the collection sheet that has been already used in our NICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
preterm infants, hindmilk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hindmilk
Arm Type
Experimental
Arm Description
Hindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hindmilk
Intervention Description
Mother will be taught to separate her milk and infant will receive only hindmilk for feeds
Primary Outcome Measure Information:
Title
Average Weight Gain
Description
Difference in weight gain the week before hindmilk and the week after
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Effect of feeding hindmilk on anthropometrics
Description
Compared to published rates in NICUs
Time Frame
At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Title
Effect of feeding hindmilk on body mass index
Description
Compared to published rates in NICUs
Time Frame
At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Title
Incidence of extra uterine growth restriction
Description
Defined as wight less than 10th percentile. Compared to published rates in NICUs
Time Frame
At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Title
Incidence of bronchopulmonary dysplasia and retinopathy of prematurity
Description
BPD will be defined according to Child Health and Human Development as the requirement for positive pressure support (CPAP or high flow nasal cannula ≥ 1 liter per minute (LPM)), or oxygen dependency at 36 corrected gestational age. ROP will be defined according to the international classification1 or requiring treatment. Compared to published rates in NICUs
Time Frame
At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Title
Correlation between human milk content (fat, protein and energy) and weight gain
Description
Linear regression analysis will be used to correct for any confounding factors
Time Frame
Within 4 weeks of enrollment
Title
Effect of hindmilk on erythrocyte membranes fatty acids profile.
Description
Comparison between sample taken at 24 hours and sample at week 2-4 after hindmilk
Time Frame
Within 4 weeks of enrollment
Title
Changes in mother's milk volumes after feeding hindmilk.
Description
Monitor the milk output of mothers throughout the study
Time Frame
Until 36 weeks post menstrual age and/or discharge (up to 13 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria Congenital anomalies Small for gestational age infants (< 10th percentile) at birth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belal Alshaikh, MD, MSc
Phone
403-955-2320
Email
belal.alshaikh@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Towage, MD
Email
zainab.towage@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD, MSc
Phone
403-955-2320
Email
belal.alshaikh@ahs.ca
First Name & Middle Initial & Last Name & Degree
Zainab Towage, MD
Email
zainab.towage@ahs.ca
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD, MSc
First Name & Middle Initial & Last Name & Degree
Zainab Towage, MD
First Name & Middle Initial & Last Name & Degree
Kamran Yusuf, MD
First Name & Middle Initial & Last Name & Degree
Wissam Alburaki, MD
First Name & Middle Initial & Last Name & Degree
Christel Major, RN, LC
First Name & Middle Initial & Last Name & Degree
JillMarie Spence, RD
First Name & Middle Initial & Last Name & Degree
Jannette Festival, RN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Hindmilk on Growth Velocity of Very Preterm Infants

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