Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000218695
Ethics application status
Approved
Date submitted
20/02/2014
Date registered
28/02/2014
Date last updated
3/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Kangaroo Mother Care and Its Lactogenic Effects
Scientific title
Prolactin Level and Breastmilk Production among Mothers of Low Birth Weight Infants Admitted to Level II Neonatal Intensive Care Unit of the Philippine General Hospital who underwent Kangaroo Mother Care
Secondary ID [1] 284137 0
None
Universal Trial Number (UTN)
U1111-1153-2711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lactogenic Effects 291220 0
Low Birth Weight Infants 291263 0
Condition category
Condition code
Reproductive Health and Childbirth 291566 291566 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kangaroo Mother Care (KMC) is an alternative technique developed by Rey in 1978 for care of low birth weight infants. In this method, the infants will be placed on continuous skin to skin contact between the mother and the baby. The mother will keep her newborn infant between the breasts, in close contact with her body and will be covered with the kangaroo tube for 4 hours minimum per day for 7 days. The infants will only wear a diaper and a cap. Breastfeeding will be the standard feeding method.
Intervention code [1] 288832 0
Treatment: Other
Comparator / control treatment
Conventional method of care is the routine care offered in the neonatal unit to low birth weight infants. This generally includes: an artificial warming system (heated room overhead lamp warmers). Observation period will last for 7 days.
Control group
Active

Outcomes
Primary outcome [1] 291521 0
Maternal serum prolactin:
A 4mL blood sample will be obtained from the mothers and sent to laboratory for radioimmuno-assay (expressed in mIU/L). Samples sent will only contain study code to maintain concealment of identity and ensure blinding of laboratory personnel to the allocation.
Timepoint [1] 291521 0
Outcome will be assessed on on day 3 and day 7 postpartum days/days of life/intervention days (please note that mother-baby dyad will be enrolled upon delivery)
Primary outcome [2] 291522 0
Expressed Milk Volume:
Mothers will undergo milk extraction via breast pump machine. The adequacy of breast milk emptying will be assessed by the lactation nurses that are not involved in the study and are blinded in the allocation. They will likewise measure the milk volume using volumetric flask (expressed in millilitres)
Timepoint [2] 291522 0
Outcome will be assessed on day 3 and day 7 postpartum days/days of life/intervention days (please note that mother-baby dyad will be enrolled upon delivery)
Secondary outcome [1] 306966 0
Infant's weight gain:
All babies will be weighed using similar electronic weighing scale (expressed in grams)
Timepoint [1] 306966 0
Daily for 7 days after enrolment/post-partum days/days of life (please note that mother-baby dyad will be enrolled upon delivery)

Eligibility
Key inclusion criteria
Mother-baby dyad: Mothers who gave birth to neonates less than or equal to 2000 grams with an APGAR score of more than or equal to 7 on the fifth minute of life.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Mothers who gave birth to Extremely Low Birth Weight Infants (ELBW).
b. Mothers who gave birth to neonates with chromosomal and life threatening congenital anomalies.
c. Mothers who gave birth to severely ill neonates requiring intubation, oxygen or inotropic support.
d. Mothers who are severely ill requiring intubation or any form of oxygen support.
e. Mothers who had Mastectomy.
f. Mothers diagnosed with Prolactinoma.
g. Mothers who are mentally ill.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All prospective candidates (mothers in labor satisfying the criteria) will be informed of the ongoing study and their possible inclusion. This will be done by the resuscitation team in the delivery room. After the delivery of the infant, once the candidate fulfils the enrolment criteria, an informed consent will be taken by the primary investigator in the delivery room. Allocation to study group will be done via sequentially numbered opaque sealed envelopes upon admission in the NICU.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After informed consent is obtained from the patient, they will be randomized using a table of random numbers from a statistics book with codes placed in sequentially numbered opaque sealed envelope by a person not involved in the study to ensure concealment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 25 subjects for each of the control and treatment arm was calculated to achieve a power of 80% and an alpha error of 0.05. We will employ student’s T test and Pearson Chi-square for continuous and dichotomous data respectively. A p value of < 0.5 is considered statistically significant

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
19/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5845 0
Philippines
State/province [1] 5845 0
Philippines

Funding & Sponsors
Funding source category [1] 288770 0
Charities/Societies/Foundations
Name [1] 288770 0
Bless Tetada Kangaroo Care Mother Foundation, Philippines
Country [1] 288770 0
Philippines
Primary sponsor type
University
Name
University of the Philippines
Address
4th Flr, Philippine General Hospital
Taft. Avenue, Ermita, Manila, 1000
Country
Philippines
Secondary sponsor category [1] 287469 0
None
Name [1] 287469 0
Address [1] 287469 0
Country [1] 287469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290610 0
University of the Philippines Manila Review Ethics Board
Ethics committee address [1] 290610 0
Ethics committee country [1] 290610 0
Philippines
Date submitted for ethics approval [1] 290610 0
16/09/2013
Approval date [1] 290610 0
20/01/2014
Ethics approval number [1] 290610 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46414 0
Dr Peter Francis N. Raguindin
Address 46414 0
University of the Philippines Manila
Philippine General Hospital
Department of Pediatrics
Taft Ave., Ermita, Manila, Philippines 1000
Country 46414 0
Philippines
Phone 46414 0
+63 922 8471964
Fax 46414 0
Email 46414 0
[email protected]
Contact person for public queries
Name 46415 0
Peter Francis N. Raguindin
Address 46415 0
University of the Philippines Manila
Philippine General Hospital
Department of Pediatrics
Taft Ave., Ermita, Manila, Philippines 1000
Country 46415 0
Philippines
Phone 46415 0
+63 922 8471964
Fax 46415 0
Email 46415 0
[email protected]
Contact person for scientific queries
Name 46416 0
Peter Francis N. Raguindin
Address 46416 0
University of the Philippines Manila
Philippine General Hospital
Department of Pediatrics
Taft Ave., Ermita, Manila, Philippines 1000
Country 46416 0
Philippines
Phone 46416 0
+63 922 8471964
Fax 46416 0
Email 46416 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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Dumalag JAA, Uy MEV, Raguindin PF. 2021. Prolactin... [More Details] 365839-(Uploaded-03-01-2022-20-39-26)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.