Lactoferrin Infant Feeding Trial - LIFT_Canada

NCT03367013 | Completed Phase 3 DMC

• 1 other identifier: 0890
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Preterm Infant; Very Low Birth Weight Infant; Morbidity;Newborn

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Incidence of all-cause in-hospital mortality

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

• Incidence of each of the 5 components of the composite primary endpoint

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

• Incidence of chronic lung disease at 36 weeks CG

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

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

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

• Number of blood transfusions

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

The 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.

Dietary Supplement: Bovine Lactoferrin

Control Group

SHAM COMPARATOR

The 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.

Other: No Bovine Lactoferrin added

Interventions

Bovine Lactoferrin DIETARY_SUPPLEMENT

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.

Also known as: Lactoferrin-250

Intervention Group

No Bovine Lactoferrin added OTHER

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.

Control Group

Eligibility Criteria

• Age: 2 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Elizabeth Asztalos: lead
• Sunnybrook Research Institute (Toronto, Ontario): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (9)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Children's and Women's Health Centre BC

Vancouver, British Columbia, Canada

Location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Location

Saint Boniface Hospital

Winnipeg, Manitoba, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Related Publications (7)

• 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.

  PMID: 12622582 BACKGROUND

• 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.

  PMID: 19117897 BACKGROUND

• 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.

  PMID: 17548764 BACKGROUND

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

  PMID: 19318940 BACKGROUND

• 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.

  PMID: 19642220 BACKGROUND

• 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.

  PMID: 11158457 BACKGROUND

• 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.

  PMID: 31996186 DERIVED

Related Links

• Canadian Neonatal Network. Accessed September 30, 2016.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Elizabeth Asztalos, MD,MSc,FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: February 22, 2018
• Primary Completion: July 27, 2022
• Study Completion: November 25, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)