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

Low Birth Weight Among Neonates Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085382
• Other study ID #: NIH 2011-014
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2014
• Last updated: March 10, 2014
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: National Institutes of Health - Research Management Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight Among Neonates
• Weight Gain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Philippines	Philippine General Hospital - University of the Philippines Manila	Manila	National Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
University of the Philippines	Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes