Back to resultsRandomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates
Primary Purpose
Low Birth Weight Among Neonates
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Kangaroo Mother Care
Conventional Mother Care
Sponsored by
About this trial
This is an interventional supportive care trial for Low Birth Weight Among Neonates focused on measuring Kangaroo Mother Care(KMC), Low-birth weight, neonates
Eligibility Criteria
Inclusion Criteria:
- birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
- normal heart rate (120-160 bpm), normal blood pressure per age
- no apnea
- no intravenous lines or with well-secured peripheral line
- no sepsis
- no emerging signs of sepsis
- on IV antibiotic therapy but clinically stable
- can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.
Exclusion Criteria:
- neonates with chromosomal and life threatening congenital anomalies, who were severally ill
- whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.
Sites / Locations
- Philippine General Hospital - University of the Philippines Manila
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Kangaroo Mother Care Group
Conventional Mother Care
Arm Description
Mothers in the KMC group were oriented in detail about KMC procedure. The mothers provided skin to skin contact using a specially tailored "kangaroo tube" made of soft flannel cloth. The mothers were encouraged to keep the baby in KMC as long as possible during the day and night for an accumulated time of at least 6 hours per day. The duration of the kangaroo care by each of the mother were recorded and tallied accordingly.
Conventional method of care was the routine care offered in the neonatal unit to low birth weight infants.
Outcomes
Primary Outcome Measures
Low Birth Weight
Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.
Secondary Outcome Measures
Full Information
NCT ID
NCT02085382
First Posted
March 6, 2014
Last Updated
March 10, 2014
Sponsor
University of the Philippines
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02085382
Brief Title
Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates
Official Title
A Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Low Birth Weight Neonates Admitted in Level II Neonatal Intensive Care Unit of the Philippine General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.
Detailed Description
A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight Among Neonates
Keywords
Kangaroo Mother Care(KMC), Low-birth weight, neonates
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kangaroo Mother Care Group
Arm Type
Other
Arm Description
Mothers in the KMC group were oriented in detail about KMC procedure. The mothers provided skin to skin contact using a specially tailored "kangaroo tube" made of soft flannel cloth. The mothers were encouraged to keep the baby in KMC as long as possible during the day and night for an accumulated time of at least 6 hours per day. The duration of the kangaroo care by each of the mother were recorded and tallied accordingly.
Arm Title
Conventional Mother Care
Arm Type
Other
Arm Description
Conventional method of care was the routine care offered in the neonatal unit to low birth weight infants.
Intervention Type
Procedure
Intervention Name(s)
Kangaroo Mother Care
Intervention Description
The infants were placed on continuous skin to skin contact between the mother and the baby as soon as possible. The mother kept her newborn infant between the breast, in close contact with her body and covered with the kangaroo tube. Infants wore diaper and a cap during the procedure. Breastfeeding was the standard feeding method.
When the baby was not in KMC, the baby was placed in the bassinet under warm lamp, if needed, adequately clothed and covered.
Intervention Type
Procedure
Intervention Name(s)
Conventional Mother Care
Intervention Description
This is generally included: an artificial warming system (heated room overhead lamp warmers). Breastfeeding was also the standard feeding method but if indicated, babies can also be fed through tube or cup feeding. The mothers were allowed to visit their babies anytime but skin to skin contact was not allowed.
Babies in both groups were monitored hourly. Their heart rate, respiratory rate and temperature were monitored and recorded. Any untoward events like hypothermia, hypoglycemia, apnea, signs of sepsis, and feeding problems were also noted.
Primary Outcome Measure Information:
Title
Low Birth Weight
Description
Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
normal heart rate (120-160 bpm), normal blood pressure per age
no apnea
no intravenous lines or with well-secured peripheral line
no sepsis
no emerging signs of sepsis
on IV antibiotic therapy but clinically stable
can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.
Exclusion Criteria:
neonates with chromosomal and life threatening congenital anomalies, who were severally ill
whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faye S De Ocampo, Medical Doctor
Organizational Affiliation
Department of Pediatrics College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital - University of the Philippines Manila
City
Manila
State/Province
National Capital Region
ZIP/Postal Code
1000
Country
Philippines
12. IPD Sharing Statement
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Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates
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