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Weight GainNCT03637413

Effect of Hindmilk on Growth Velocity of Very Preterm Infants

A study testing Hindmilk in people with Weight Gain, run by Belal Alshaikh at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 weeks and older
Conditions the study is for
Weight Gain
What is being tested?
Hindmilk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteCanada
Study dates
22 Jan 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belal Alshaikh, MD, MSc contact

403-955-2320

belal.alshaikh@ahs.ca

Zainab Towage, MD contact

zainab.towage@ahs.ca

Canada1 site, 1 recruiting
  • Foothills Medical Centre

    Calgary, Alberta, T2N2T9

    Belal Alshaikh, MD, MSc, 403-955-2320, belal.alshaikh@ahs.ca

    Zainab Towage, MD, zainab.towage@ahs.ca

    Recruiting

Other trials in Canada

About this study

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

Read the 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.

Conditions
Weight Gain
Being tested
Hindmilk
Keywords
preterm infants, hindmilk
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HindmilkDietary supplement

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

Study groups in NCT03637413
Study groupRoleWhat they receive
HindmilkExperimentalHindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk.
Receives: Dietary Supplement: Hindmilk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Weight Gain

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

    Measured: 2 weeks

Secondary outcomes (7)
  1. Effect of feeding hindmilk on anthropometrics

    Compared to published rates in NICUs

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

  2. Effect of feeding hindmilk on body mass index

    Compared to published rates in NICUs

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

  3. Incidence of extra uterine growth restriction

    Defined as wight less than 10th percentile. Compared to published rates in NICUs

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

  4. 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

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

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

    Linear regression analysis will be used to correct for any confounding factors

    Measured: Within 4 weeks of enrollment

  6. Effect of hindmilk on erythrocyte membranes fatty acids profile.

    Comparison between sample taken at 24 hours and sample at week 2-4 after hindmilk

    Measured: Within 4 weeks of enrollment

  7. Changes in mother's milk volumes after feeding hindmilk.

    Monitor the milk output of mothers throughout the study

    Measured: Until 36 weeks post menstrual age and/or discharge (up to 13 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start22 Jan 2019
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637413
Sponsor's protocol ID
REB18-0195
Status last verified
Nov 2022
First submitted
14 Aug 2018
Last updated
7 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hindmilk in people with Weight Gain, run by Belal Alshaikh at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Belal Alshaikh, MD, MSc (403-955-2320, belal.alshaikh@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Weight Gain (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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