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

NCT ID: NCT02085382

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Low Birth Weight Among Neonates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Kangaroo Mother Care

Intervention Type: 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.

Conventional Mother Care

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

Group Type: OTHER

Conventional Mother Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of the Philippines

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faye S De Ocampo, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics College of Medicine

Locations

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

NIH 2011-014

Identifier Type: -

Identifier Source: org_study_id