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.
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.
Zainab Towage, MD contact
Canada1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Hindmilk | Experimental | Hindmilk, 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.
Average Weight Gain
Difference in weight gain the week before hindmilk and the week after
Measured: 2 weeks
Secondary outcomes (7)
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)
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)
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)
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)
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
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
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.
- First posted20 Aug 2018
- Study start22 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Belal Alshaikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belal Alshaikh, University of Calgary
- Investigators
- Belal Alshaikh, MD, MSc, Principal investigator, University of Calgary
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hindmilk on Growth Velocity of Very Preterm Infants
- ClinicalTrials.gov ID
- NCT03637413
- Acronym / sponsor ID
- REB18-0195
- Conditions
- Weight Gain
- Keywords
- preterm infants, hindmilk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Belal AlshaikhUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hindmilk | Experimental | Dietary Supplement: HindmilkHindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk. |
Who may qualify
- Ages
- 2 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Congenital anomalies
- Small for gestational age infants (< 10th percentile) at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HindmilkMother will be taught to separate her milk and infant will receive only hindmilk for feeds | Dietary supplement | Hindmilk |
Primary outcome
Average Weight Gain
Time frame: 2 weeks
Difference in weight gain the week before hindmilk and the week after
7 secondary outcomes
Effect of feeding hindmilk on anthropometrics
Time frame: At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Effect of feeding hindmilk on body mass index
Time frame: At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Incidence of extra uterine growth restriction
Time frame: At 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Incidence of bronchopulmonary dysplasia and retinopathy of prematurity
Time frame: 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
Time frame: Within 4 weeks of enrollment
Effect of hindmilk on erythrocyte membranes fatty acids profile.
Time frame: Within 4 weeks of enrollment
Changes in mother's milk volumes after feeding hindmilk.
Time frame: Until 36 weeks post menstrual age and/or discharge (up to 13 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab Towage, MD contact
Belal Alshaikh, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
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.