Completed

NCT Number: NCT02085382

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

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.

Completed

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Key information

Conditions

Low Birth Weight Among Neonates

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, 1000, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Low Birth Weight

Time frame: 3 days

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.

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Collaborators

Pfizer

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 12, 2014
Registry last updated: Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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