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

University of the Philippines

Status and phase: Completed; Phase 3

Conditions: Low Birth Weight Among Neonates

Treatments: Procedure: Kangaroo Mother Care; Procedure: Conventional Mother Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02085382

NIH 2011-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

Kangaroo Mother Care Group

Other group

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.

Treatment:

Procedure: Kangaroo Mother Care

Conventional Mother Care

Other group

Description:

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

Treatment:

Procedure: Conventional Mother Care