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Preterm InfantPhase 3NCT03367013

Lactoferrin Infant Feeding Trial - LIFT_Canada

A Phase 3 study testing Bovine Lactoferrin and No Bovine Lactoferrin added in people with Preterm Infant and Very Low Birth Weight Infant, run by Dr. Elizabeth Asztalos at 9 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants. Read more about this study

Who is it for?
Ages 2 to 7 days
What is being tested?
Bovine Lactoferrin and No Bovine Lactoferrin added
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
453 participants
Where
9 sitesCanada
Study dates
22 Feb 2018to 25 Nov 2024
Phase
Phase 3
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 to 7 days
  • All sexes
  • No healthy volunteers
  • Child

An infant will be able to participate once a parent or guardian has provided a written informed consent and the infants must meet all of the following inclusion criteria:

  • <1500 g at birth
  • 2-7 days old and not moribund
  • infant is considered to be stable by the clinical care team
  • has initiated feeds

Any infant meeting any of the following exclusion criteria will be excluded from participation in this study

  • severe congenital anomalies which are likely to cause death or known to contribute to an adverse neurodevelopmental outcome
  • major congenital gastrointestinal anomalies which will prevent an early approach to feeding
  • parents unable to provide informed consent

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • Foothills Medical Centre

    Calgary, Alberta

  • IWK Health Centre

    Halifax, Nova Scotia

  • McMaster Children's Hospital

    Hamilton, Ontario

  • The Ottawa Hospital

    Ottawa, Ontario

  • Mount Sinai Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Children's and Women's Health Centre BC

    Vancouver, British Columbia

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba

  • Saint Boniface Hospital

    Winnipeg, Manitoba

Other trials in Canada

About this study

This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants.

Read the detailed description

Almost 3,000 very low birth weight (VLBW), <1500g preterm infants are born and treated in Canada annually. About 1,200 either die or survive with severe brain or lung injury, retinopathy, late-onset sepsis or necrotizing enterocolitis (NEC), each of which is associated with substantial risk of childhood disability.

Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying, bifidogenic glycoprotein found in all vertebrates and in mammalian milk, leukocytes and exocrine secretions. However, most VLBW infants receive insufficient human lactoferrin (hLF) from human breast milk in the first months of life, resulting in suboptimal protection. Because hLF is expensive, bovine lactoferrin (bLF) has been considered as an alternate supplement to improve this suboptimal protection.

LIFT is one of several ongoing trials using higher doses of bovine bLF in the VLBW population (120-200 mg/kg/d). If LIFT confirms a 19% reduction in the relative risk of its primary outcome, bLF will have a major impact, translating into thousands more intact survivors without major morbidity in Australia, New Zealand, Canada, Europe and worldwide each year. As >90% of very preterm survivors at hospital discharge reach adulthood, this represents more than 19,000 life-years gained in Canada alone each year, one of the largest gains in intact survival in any specialty since neonatal surfactant and antenatal steroids

Being tested
Bovine Lactoferrin, No Bovine Lactoferrin added
Medical subject headings
Premature Birth

What participants receive

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

  • Bovine LactoferrinDietary supplement

    Also called Lactoferrin-250

    Intervention includes a daily dose of 200 mg/kg bovine lactoferrin in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

  • No Bovine Lactoferrin addedOther

    Control includes daily study feed with no bovine lactoferrin added in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

Study groups in NCT03367013
Study groupRoleWhat they receive
Intervention GroupExperimentalThe intervention group will receive a daily dose of 200 mg/kg of bovine lactoferrin in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.
Receives: Dietary Supplement: Bovine Lactoferrin
Control GroupSham comparatorThe control group will receive daily study feed with no bovine lactoferrin added in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.
Receives: Other: No Bovine Lactoferrin added

What is being measured

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

  1. Hospital mortality or major morbidity

    Hospital mortality or major morbidity at 36 weeks corrected gestation defined as:

    • Brain injury on ultrasound
    • Necrotizing enterocolitis (Bell stage II or higher )
    • Late onset sepsis (≥ 72 hours of life, culture proven), or

    Retinopathy of prematurity treated according to local guidelines before discharge from hospital.

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier.

Secondary outcomes (8)

  1. Incidence of all-cause in-hospital mortality

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  2. Incidence of each of the 5 components of the composite primary endpoint

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  3. Incidence of chronic lung disease at 36 weeks CG

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  4. Time to first day of full enteral feeds (≥120ml/kg/day for 3 consecutive days)

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  5. Number of blood transfusions

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  6. Length of hospital stay

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  7. Weight and head circumference at 36 weeks corrected gestation

    Measured: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

  8. Incidence of death by 24 months corrected age or the presence of neurodevelopmental outcomes at 24 months corrected age

    Incidence of death by 24 months corrected age or the presence of major neurodevelopmental outcomes at 24 months corrected age, as defined: (i) visual (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes), or hearing impairment (requiring a hearing aid or cochlear implants); (ii) cerebral palsy with an inability to walk unassisted; (iii) major developmental delay involving cognition or speech (composite score < 85 for cognition or language on assessment)

    Measured: Randomization to 36 weeks corrected gestation

Timeline

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

  1. First posted8 Dec 2017
  2. Study start22 Feb 2018
  3. Primary completion27 Jul 2022
  4. Study completion25 Nov 2024

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367013
Sponsor's protocol ID
0890
Status last verified
Nov 2024
First submitted
4 Dec 2017
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003 Mar 5;289(9):1124-9. doi: 10.1001/jama.289.9.1124.

    PubMed 12622582

  • Bassler D, Stoll BJ, Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS; Trial of Indomethacin Prophylaxis in Preterms Investigators. Using a count of neonatal morbidities to predict poor outcome in extremely low birth weight infants: added role of neonatal infection. Pediatrics. 2009 Jan;123(1):313-8. doi: 10.1542/peds.2008-0377.

    PubMed 19117897

  • Schulzke SM, Deshpande GC, Patole SK. Neurodevelopmental outcomes of very low-birth-weight infants with necrotizing enterocolitis: a systematic review of observational studies. Arch Pediatr Adolesc Med. 2007 Jun;161(6):583-90. doi: 10.1001/archpedi.161.6.583.

    PubMed 17548764

  • Lonnerdal B. Nutritional roles of lactoferrin. Curr Opin Clin Nutr Metab Care. 2009 May;12(3):293-7. doi: 10.1097/MCO.0b013e328328d13e.

    PubMed 19318940

  • Albera E, Kankofer M. Antioxidants in colostrum and milk of sows and cows. Reprod Domest Anim. 2009 Aug;44(4):606-11. doi: 10.1111/j.1439-0531.2007.01027.x.

    PubMed 19642220

  • Embleton NE, Pang N, Cooke RJ. Postnatal malnutrition and growth retardation: an inevitable consequence of current recommendations in preterm infants? Pediatrics. 2001 Feb;107(2):270-3. doi: 10.1542/peds.107.2.270.

    PubMed 11158457

  • Asztalos EV, Barrington K, Lodha A, Tarnow-Mordi W, Martin A. Lactoferrin infant feeding trial_Canada (LIFT_Canada): protocol for a randomized trial of adding lactoferrin to feeds of very-low-birth-weight preterm infants. BMC Pediatr. 2020 Jan 29;20(1):40. doi: 10.1186/s12887-020-1938-0.

    PubMed 31996186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bovine Lactoferrin and No Bovine Lactoferrin added in people with Preterm Infant and Very Low Birth Weight Infant, run by Dr. Elizabeth Asztalos at 9 sites in Canada.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital mortality or major morbidity (time frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03367013, which also lists 7 linked publications.

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 29 Nov 2024; AzTrials last refreshed its copy on 5 Nov 2026.

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