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

NCT02085382 | Completed Phase 3 DMC

• 1 other identifier: NIH 2011-014
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Birth Weight Among Neonates

Keywords

Kangaroo Mother Care(KMC), Low-birth weight, neonates

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Kangaroo Mother Care Group

OTHER

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

Conventional Mother Care

OTHER

Conventional method of care was the routine care offered in the neonatal unit to low birth weight infants.

Procedure: Conventional Mother Care

Interventions

Kangaroo Mother Care PROCEDURE

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.

Kangaroo Mother Care Group

Conventional Mother Care PROCEDURE

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.

Conventional Mother Care

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Philippines: lead
• Pfizer: collaborator

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, 1000, Philippines

Location

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Faye S De Ocampo, Medical Doctor

  Department of Pediatrics College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 12, 2014
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

PH (1)