Condition category
Pregnancy and Childbirth
Date applied
04/10/2011
Date assigned
14/02/2012
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lactoferrin is a major protein in mammalian milk and is important in defence against infections. Premature babies receive very little lactoferrin. Premature babies are at very high risk of catching bacterial infections while they are in hospital. These infections can be fatal or they can have impacts on future development of the baby. One previous study suggested that lactoferrin derived from cow’s milk may reduce the risk of these fragile babies being infected. This study is being performed to confirm the previous study results, and to see if a further large multi-center trial can be performed in Canada.

Who can participate?
Preterm infants in the neonatal unit at Sainte Justine University Health Center, who are born before 31 weeks of gestation.

What does the study involve?
Babies will be randomly divided into two groups on the day that they first receive milk feeds (usually in the first few days of life). The intervention group will get lactoferrin every day mixed into their milk feeds, continuing until they are at 36 weeks or until they leave hospital if that occurs first. The control group will receive milk without added lactoferrin. There are no additional blood tests needed. This is a masked trial: lactoferrin does not change the appearance of the milk and we will not know which baby is in which group until the trial is finished. Any baby who develops signs of an infection will have the usual blood cultures taken, just as they would if they were not in the study. The main question we are asking is whether the babies are more likely to leave the hospital alive without an infection in one group or the other.

What are the possible benefits and risks of participating?
There are no known risks from receiving lactoferrin, no side effects have been described, and it does not appear to be absorbed from the intestines. All babies will receive usual medical care.

Where is the study run from?
Sainte Justine University Hospital, Montreal, Canada

When is the study starting and how long is it expected to run for?
The study started in November 2011 and ran for 6 months.

Who is funding the study?
Research Center of Sainte Justine, Canada

Who is the main contact?
Dr Keith J Barrington
keith.barrington@umontreal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Keith Barrington

ORCID ID

Contact details

CHU Sainte Justine
3175 Cote Ste Catherine
Montreal
H3T 1C5
Canada
+1 (0)514 345 4931
keith.barrington@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled pilot trial of lactoferrin for prevention of infections in very preterm newborns

Acronym

LACUNA (LACtoferrin Use in NeonAtes)

Study hypothesis

In infants who are born at gestational ages of 23 0/7 to 30 6/7 weeks, administration of bovine lactoferrin commencing within the first 48 hours of life, and continuing until 36 weeks post-menstrual age or to hospital discharge if sooner, compared with control, increases the probability of survival without a proven Healthcare-Associated Infections (HCAI) to discharge from hospital.

Ethics approval

Not provided at time of registration

Study design

Single-centre randomized blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Healthcare-associated infections in preterm infants

Intervention

Infants allocated to the treatment group will receive 100 mg per day of bovine lactoferrin, divided into two doses per day. This will start on the first day of enteral feeding (day of enrolment) or at the latest at 48 hours of age and they will receive it daily until 36 weeks post-menstrual age (PMA) or discharge home.

Control infants receive milk without lactoferrin

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Death or at least one HCAI before discharge home
2. Tolerance of lactoferrin

Secondary outcome measures

1. Infections per 1000 patient days. Because some infants may experience more than one HCAI during their stay, and others may be transported to level 2 step-down units prior to discharge home, other analyses of infection rates are required. Calculation of the number of infections per 1000 patient days corrects for some of these factors.
2. Necrotizing Enterocolitis (NEC): The diagnostic criteria for NEC which will be used as the primary outcome will be the modified Bell’s criteria, stage 2 or more, i.e. a clinical diagnosis of necrotizing enterocolitis with, in addition pneumatosis intestinalis or portal venous gas, or a surgical or autopsy diagnosis of NEC.
3. Surgical intervention for NEC, or spontaneous intestinal perforation will be recorded
4. Death ascribed to acute effects of sepsis

Overall trial start date

01/11/2011

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Preterm infants in the neonatal intensive care unit (NICU) at CHU Sainte Justine, with a gestational age at birth of 23 0/7 to 30 6/7 weeks who are less than 48 hours of age

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

80

Participant exclusion criteria

Intestinal abnormailities preventing enteral feeding, such as gastroschisis

Recruitment start date

01/11/2011

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Canada

Trial participating centre

CHU Sainte Justine
Montreal
H3T 1C5
Canada

Sponsor information

Organisation

Research Center of CHU Sainte-Justine [Centre de Recherche de CHU Sainte-Justine] (Canada)

Sponsor details

3175 Chemin de la Côte-Sainte-Catherine
Québec
Montreal
H3T 1C5
Canada

Sponsor type

Research organisation

Website

http://www.chu-sainte-justine.org/recherche/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26938920

Publication citations

Additional files

Editorial Notes

07/03/2016: Publication reference added.