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Trial registered on ANZCTR


Registration number
ACTRN12618000644268
Ethics application status
Approved
Date submitted
19/11/2017
Date registered
23/04/2018
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Administration of Mother's Colostrum to Premature Newborns.
Scientific title
Oropharyngeal Administration of Maternal Colostrum to Preterm Infants Targeting Neonatal Outcomes.
Secondary ID [1] 293344 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 305444 0
Neonatal Sepsis 305445 0
Necrotizing Enterocolitis 305446 0
Condition category
Condition code
Reproductive Health and Childbirth 304719 304719 0 0
Breast feeding
Reproductive Health and Childbirth 305607 305607 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neonates on group 1 receive 0.2 mL of own mother's colostrum administered by the nurse. Process: one syringe will be placed on the patient’s right or left buccal mucosa, and the colostrum drops will administered toward the posterior oropharynx for at least 10 seconds. Treatment period of every 3 hours for 72 consecutive hours. A member of the study staff will follow up periodically and randomly the colostrum administration.
Intervention code [1] 299596 0
Prevention
Comparator / control treatment
Neonates on group 2 receive 0.2 mL of placebo (sterile water) administered by the nurse. Process: one syringe will be placed on the patient’s right or left buccal mucosa, and the placebo drops will administered toward the posterior oropharynx for at least 10 seconds. Treatment period of every 3 hours for 72 consecutive hours. This process will be closely monitored by the study staff. A member of the study staff will follow up periodically and randomly the placebo administration.
Control group
Placebo

Outcomes
Primary outcome [1] 303922 0
Incidence of Sepsis

Clinical sepsis is defined as clinical signs of infection accompanied by concurrent antibiotic treatment of .3 days.

Clinical signs of infection included all 3 of the
following categories and at least 1 sign in each of the 3 categories:
- General Signs (fever, apnea/tachypnea,respiratory distress, positive fluid balance),
- Laboratory Results (leukopenia/leukocytosis, increased C-reactive protein),
- Hemodynamic Alterations (hypotension, tachycardia, altered skin perfusion, decreased
urine output, increased base deficit).

This outcome will be assess by hospital records.
Timepoint [1] 303922 0
at 15 days after birth
Primary outcome [2] 303958 0
Incidence of Necrotizing Enterocolitis

Necrotizing Enterocolitis is defined according to modified Bell’s criteria stage >2 with clinical
signs and radiological evidence including any of the following: pneumatosis intestinalis, portal venous gas with or without pneumoperitoneum.

This outcome will be assess by hospital records.
Timepoint [2] 303958 0
at 15 days after birth
Primary outcome [3] 303959 0
Incidence of Ventilator-Associated Pneumonia

Ventilator-Associated Pneumonia is defined as clinical signs of pneumonia combined with pneumonic infiltration on greater than or equal to 2 serial chest radiographs in patients receiving mechanical ventilation for greater than or equal to 48 hours.

Clinical signs of pneumonia included worsening gas exchange, increased oxygen requirements, increased ventilator demand, and greater than or equal to 1 clinical symptoms (new onset of purulent sputum, temperature instability, eukopenia/leukocytosis with left shift, apnea/ tachypnea, or bradycardia/tachycardia).


This outcome will be assess by hospital records.
Timepoint [3] 303959 0
at 15 days after birth
Secondary outcome [1] 340472 0
Time to Reach Full Enteral Feeds

Is defined as number of days elapsed until newborn reaches a minimum enteral tolerance of 100 mL/kg/day.

This outcome will be assess by hospital records.
Timepoint [1] 340472 0
at 15 days after birth
Secondary outcome [2] 340541 0
Length of NICU Stay

Is defined as neonate's days of stay in neonatal intensive care unit will be counted from the first day of admission until discharge of the service.

This outcome will be assess by hospital records.
Timepoint [2] 340541 0
at 15 days after birth
Secondary outcome [3] 340603 0
Concentrations of Human Milk Oligosaccharides in mother's milk.

Total and specific Human Milk Oligosaccharides concentrations in mother's milk will be measured by using High Performance Liquid Chromatography technique.
Timepoint [3] 340603 0
Milk Collection will be done at three different timepoints. 1, 7 and 14 days postpartum.
Secondary outcome [4] 345520 0
Concentrations of Human Milk Oligosaccharides in neonate's urine.

Total and specific Human Milk Oligosaccharides concentrations neonate's urine will be measured by using High Performance Liquid Chromatography technique.
Timepoint [4] 345520 0
at 2 day after birth.

Eligibility
Key inclusion criteria
-Preterm Neonates:
NICU admission less than or equal to 72 hours of life
-Mother:
18 to 45 years old
Desire to breast feed for at least 14 days
Minimum age
27 Weeks
Maximum age
37 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Preterm Neonates:
Congenital diseases incompatible with life.
Neonatal asphyxia.
-Mothers:
Lack of colostrum production within 48 hours after recruitment
Contraindications for breastfeeding: drug addiction, diseases, HIV.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. All infants who fulfilled the inclusion criteria will be enrolled in this study.
2. Allocation sequence is generated independently by the person who has no role in the recruitment, treatment or assessment of the patient.
3. The concealment of the assignment will be guaranteed using envelopes containing the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2018
Actual
Date of last participant enrolment
Anticipated
15/08/2018
Actual
Date of last data collection
Anticipated
30/08/2018
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 9350 0
Mexico
State/province [1] 9350 0
Baja California

Funding & Sponsors
Funding source category [1] 297956 0
University
Name [1] 297956 0
Universidad Autonoma de Baja California
Country [1] 297956 0
Mexico
Primary sponsor type
Individual
Name
Diana Bueno Gutierrez
Address
11418 Ave. Tecnologico
Parque Industrial Internacional 22424
Tijuana
Baja California
Universidad Autonoma de Baja California.
Country
Mexico
Secondary sponsor category [1] 297018 0
University
Name [1] 297018 0
Universidad Autonoma de Baja California.
Address [1] 297018 0
11418 Ave. Tecnologico
Parque Industrial Internacional 22424
Tijuana
Baja California
Country [1] 297018 0
Mexico
Secondary sponsor category [2] 297030 0
Government body
Name [2] 297030 0
Instituto Mexicano del Seguro Social, Clinica 7
Address [2] 297030 0
10610 Blvd. Agua Caliente
Tijuana 22014,
Baja California, Mexico
Country [2] 297030 0
Mexico
Secondary sponsor category [3] 297780 0
University
Name [3] 297780 0
University of California, San Diego
Address [3] 297780 0
9500 Gilman Drive
San Diego
California 92093-0715
Country [3] 297780 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298998 0
Comite de Etica de Ciencias de la Salud
Ethics committee address [1] 298998 0
Facultad de Medicina y Psicologia
14418 Tecnologico
Parque Industrial Internacional
Tijuana
Baja California
Ethics committee country [1] 298998 0
Mexico
Date submitted for ethics approval [1] 298998 0
15/06/2017
Approval date [1] 298998 0
17/08/2017
Ethics approval number [1] 298998 0

Summary
Brief summary
The objective of this pilot study is to evaluate neonatal sepsis of premature infants after oropharyngeal administration of mother’s colostrum in neonatal intensive care unit (NICU). It is a randomized, controlled intervention. A total of 40 women with premature babies admitted to NICU will be recruited, where the neonates will receive 0.2 ml of colostrum or sterile water via oropharynx every 3 hours for 3 days. Milk and urine samples will be collected to analysis of the Human Milk Oligosaccharides by HPLC.

The primary hypothesis of this study is that we will find a decreased incidence of neonatal sepsis in the intervention group. The secondary hypothesis is that we will find a higher concentration of Human Milk Oligosaccharides in the group with decreased incidence of neonatal sepsis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78946 0
Prof Diana Bueno Gutierrez
Address 78946 0
Facultad de Medicina y Psicologia
14418 Ave Tecnologico
Edificio 1A
Parque industrial internacional
Tijuana
Country 78946 0
Mexico
Phone 78946 0
+52 664 68121233
Fax 78946 0
Email 78946 0
[email protected]
Contact person for public queries
Name 78947 0
Mr Javier Sanchez Fuentes
Address 78947 0
Universidad Autonoma de Baja California
Facultad de Medicina y Psicologia
14418 Ave Tecnologico
Edificio 2A
Parque industrial internacional
Tijuana
Country 78947 0
Mexico
Phone 78947 0
+52 646 9475184
Fax 78947 0
Email 78947 0
[email protected]
Contact person for scientific queries
Name 78948 0
Prof Diana Bueno Gutierrez
Address 78948 0
Facultad de Medicina y Psicologia
14418 Ave Tecnologico
Edificio 1A
Parque industrial internacional
Tijuana
Country 78948 0
Mexico
Phone 78948 0
+52 664 68121233
Fax 78948 0
Email 78948 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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