Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates

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

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight Among Neonates
• Intervention / Treatment: Procedure: Kangaroo Mother Care; Procedure: Conventional Mother Care

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • National Capital Region
    • Manila, National Capital Region, Philippines, 1000
      • Philippine General Hospital - University of the Philippines Manila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Kangaroo Mother Care Group; 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.	Procedure: Kangaroo Mother Care; 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.
Other: Conventional Mother Care; Conventional method of care was the routine care offered in the neonatal unit to low birth weight infants.	Procedure: Conventional Mother Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days

Collaborators and Investigators

• Sponsor: University of the Philippines
• Collaborators: Pfizer
• Investigators: Principal Investigator: Faye S De Ocampo, Medical Doctor, Department of Pediatrics College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Kangaroo Mother Care(KMC), Low-birth weight, neonates
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Birth Weight; Weight Gain
• Other Study ID Numbers: NIH 2011-014