Randomized Control Trial of Kangaroo Mother Care in Low Birth Weight Babies at a Tertiary Level Hospital

Introduction: This study was conducted to compare the effect of Kangaroo Mother Care (KMC) and conventional methods of care on weight gain, occurrence of hypothermia and apnea and duration of hospital stay among Low Birth Weight (LBW) babies. Materials and Methods: It was a randomized control trial conducted at a tertiary level hospital for a period of one year from June 2009 to May 2010. Total 126 stable LBW babies weighing less than 2000 gm and fulfilling inclusion criteria were included in the study. Neonates enrolled for the study were allocated to either KMC or control group using random number table. KMC group was subjected to Kangaroo mother care of at least six hours per day in not more than four sittings. In control group, babies were adequately clothed, covered and kept with their mother and if required were kept under radiant warmer. Recording of temperature in KMC group was done before, during and after KMC. In control group temperature was taken every 4 hours. Weighing of baby was done twice daily on electronic weighing scale. Results: Median daily weight gain (IQR) was 10 (620) gm in KMC group as compared to 7 (0-10) gm in control group (p<0.001). Mean weight gain was 12.11±9.04 gm in KMC group as compared to 3.29±15.81 gm in control group (p<0.001). Incidence of hypothermia was more in control group (12.6%) as compared to KMC group (3.1%) (p=0.048). Duration of hospital stay was less in control group as compared to KMC group (p=0.015). Conclusion: LBW babies less than 2000 gm who receive KMC show better weight gain and have less incidence of hypothermia than those who do not receive KMC.


Introduction
L ow Birth Weight (LBW) is defi ned as birth weight of less than 2500 grams irrespec ve of gesta onal age. It is one of the major health problems in developing countries. World-wide, twenty-fi ve million LBW infants are born each year, the great majority (96%) of them in developing countries and it cons tutes as much as 30% of births in South Asian countries 1,2 . A survey conducted in 4 regional hospitals in Nepal in 1999 showed that 20.4 to 34.7 percent of the babies are born with low birth weight 3 . According to Nepal demographic and health survey (NDHS) 2006, the incidence of LBW is 14% 4 .
In Nepal infant and neonatal mortality and morbidity is very high: Infant mortality rate is 48 per 1000 live births. Neonatal mortality rate is 33 per 1000 live births and perinatal mortality rate is 45 per 1000 births 4 . It is es mated that in Nepal nearly 50,000 children under one year of age die every year. Two third of them die within 28 days of age, resul ng in over 30,000 neonatal deaths per year. Among those dying within the neonatal period, 20,000 (two third) die in the fi rst week of life. Among those dying within the fi rst week of life, more than 16,000 die within the fi rst 24 hours. As things stand, this means that three to four This work is licensed under a Creative Commons Attribution 3.0 License. newborns are dying every hour in Nepal 5 . When babies are small or very small sized at birth, they have higher chance of mortality 4 . Hypothermia is one of the major underlying contributors to morbidity in LBW infants and predisposes them to infec on and mortality during both the neonatal period and infancy 2 . In industrialized countries, there are suffi cient basic equipments like incubators and radiant warmers and good fi nancial resources for highly sophis cated neonatal care. They have well equipped nurseries with adequate trained skilled manpower 6 . But in our part, there is lack of equipments like warmers and incubators. Incubators and other equipments, for instance, where available, are o en insuffi cient to meet local needs. Purchase of the equipment and spare parts, maintenance and repairs are diffi cult and costly; the power supply is intermi ent, so the equipments do not work properly. Under such circumstances good care of preterm and LBW babies is diffi cult. Hypothermia is frequent, aggrava ng the poor outcomes due to prematurity 6,7,8 .
Kangaroo mother care (KMC) is humane, low cost technique for care of preterm low birth weight infants which can be started early and can be easily done both in hospital and even at home a er the discharge of the baby 6,7 . It is a powerful, easy-to-use method to promote the health and well-being of infants born preterm and LBW 7 . During KMC, mothers func on somewhat like human incubators, providing physiological homeostasis, appropriate s mula on, and the main source of nutri on. Basic physiological variables such as temperature, oxygena on and heart rate are maintained within clinically acceptable limits in the kangaroo posi on 12 .

Materials and Methods
Design and study popula on: This was a randomized control trial conducted in newborn nursery BPKIHS Dharan for a period of one year from June 2009 to May 2010.
Inclusion and Exclusion criteria: Inclusion criteria were LBW babies with birth weight <2000 gm admi ed in new born Nursery. Exclusion criteria were cri cally ill babies requiring ven llatory or ionotropic support or radiant warmer, babies with chromosomal and life threatening congenital anomalies, babies whose mothers are cri cally ill and babies whose mothers do not consent for study Randomiza on and interven on: Total 126 neonates who fulfi lled the above men oned inclusion criteria were included in the study. Neonates enrolled for the study were allocated to either KMC group or control group by using a random number table. Before star ng Kangaroo Mother Care, the method of care and its benefi ts were explained to par cipa ng mothers and at least one other family member. Mothers and staff s were also informed and asked to look for dangers signs such as apnea, cyanosis during KMC so that ac on could be taken immediately. Once both baby and mother were ready, the KMC group was subjected to Kangaroo mother care of at least 6 hours per day in not more than 4 si ngs, each si ng of at least 1 hour. During Kangaroo care, mother wore a loose blouse and the baby was held upright between the breasts and the limbs were fl exed and the head was turned to one side not much fl exed or extended. Babies wore only diaper and a cap during the period of KMC. The blouse covered the infant's trunk and extremi es but not the head. The baby was further supported by 3 meters long fl annel clothes which was wrapped around mother's chest from outside her blouse. Then mother was seated in a comfortable posi on. The mother was encouraged to hold her baby in this posi on for at least 1 hour. If the baby passed urine and/or stool during the procedure and she felt discomfort she was asked to change the diaper and con nue KMC. Just before star ng KMC, baby was breast fed or tube fed; no feeding was given during KMC. When babies were not in KMC, they were adequately clothed and kept covered. The mothers were provided KMC chart to keep the records of dura on of KMC. In control group babies were adequately clothed, covered and kept with their mother. If babies in control group did not maintain temperature, they were kept under radiant warmer.
Anthropometry: Weighing of baby was done twice a day before feeding on an electronic weigh ng scale (seca 374) with sensi vity of 10 gms. Length was taken at admission and at the me of discharge with infantometer. Head circumference was measured at admission and at discharge with a non stretchable tape.
Monitoring: Recording of temperature of baby in kangaroo group was done before, during and a er KMC with a thermometer kept in axilla for 5 minutes. When not in KMC, temperature was taken every 4 hours. Axillary temperature in control group was taken every 4 hours. Babies requiring phototherapy were temporarily withdrawn from KMC group and later included when off phototherapy. All details of the delivery were recorded in proforma. Modes of delivery, birth weight, APGAR score, gesta onal age, date of admission, weight at star ng of KMC, mother's informa on (name, age, gravida/parity), were taken from neonatal problem sheet. Gesta onal age assessed by the modifi ed Ballard's score that was done within 24 hours was also noted from the problem sheet. Babies were monitored for apnea, sepsis, hyperbilirubinemia, serious illness, feeding, weight gain and dura on of stay in hospital.
Outcome assessment: Primary outcomes; Average weight gain, Occurrence of hypothermia and Occurrence of apnoea. Secondary outcome; Dura on of hospital stay.
Data Analysis: Data was recorded on a pre designed performa. Collected data was entered in MS Excel sheet. Subsequently data was analysed using SPSS sta s cal so ware (version 17). Appropriate tests of signifi cance were applied accordingly.

Results
Interpreta on: Table 1 displays baseline neonatal characteris cs in two groups. All characteris cs were comparable between 2 groups except weight at enrollment which was higher in control group. In mul variate analysis weight at enrollment was comparable between two groups (p= 0.106).
Median daily weight gain (IQR) was 10 (6-20) gm in KMC group as compared to 7 (0-10) gm in the control group which is highly signifi cant (p<0.001). Mean weight gain was 12.11±9.04 gm in KMC group as compared to 3.29±15.81gm in the control group which is also highly signifi cant (p<0.001). In KMC group 3.1% babies and in the control group 12.6% babies developed hypothermia during the study period which is sta s cally signifi cant (p=0.048). Dura on of hospital stay was less in the control group as compared to KMC group (p=0.015). This is also sta s cally signifi cant. Average increase in length and head circumference was comparable in both groups.

Discussion
There are diff erent methods and equipments used to prevent hypothermia in newborn babies. Kangaroo Mother Care is one of the methods which can be applied in thermal protec on of the LBW babies. It provides eff ec ve thermal control with reduced risk of hypothermia in stable babies. KMC is at least equivalent to conven onal care with incubators in terms of safety and thermal protec on. There are considerable numbers of LBW babies being delivered and taken care of in the Neonatal unit of BPKIHS. Data from BPKIHS shows that the incidence of LBW babies was 19% from June 2009 to May 2010.
This randomized control trial conducted at the Pediatric Nursery BPKIHS Dharan over a period of one year from June 2009 to May 2010 compares the eff ect of KMC and conven onal methods of keeping the baby warm and their eff ect on weight gain, dura on of hospital stay and occurrence of hypothermia and apnoea in low birth weight babies.
In this study babies were from various districts of eastern region and few from neighboring places of India thus covering large geographic area. In both the groups, baseline neonatal characteris cs were comparable except weight at enrollment which was higher in control group. This diff erence occurred despite careful randomiza on. To eliminate possible confounding of fi nal result by this diff erence, mul variate analysis was done in this study. Two variables where P value was <0.20 (birth weight and weight at enrollment) in univariate analysis were analysed again. In mul variate analysis, it was found that both variables were not signifi cant (P 0.373, P 0.106).So we can conclude that in randomiza on univariate analysis is signifi cant because of chance only.
Mean daily weight gain of babies in KMC group was 12.11±9.04 gm. Median daily weight gain was 10 (6-20) gm in KMC babies. In control group mean daily weight gain of babies was 3.29±15.81 gm. Median daily weight gain was 7 (0-10) gm in control. Both the results are sta s cally signifi cant (p<0.001) which shows that babies receiving KMC show be er weight gain as compared to those receiving conven onal method of care (CMC).
This fi nding is comparable with study done by Rao et al which showed that KMC babies had be er average weight gain per day (KMC: 23.99 gm vs CMC 15.58 gm p<0.0001) 14 .
It was also comparable with study by Ramanathan et al which showed that neonates in the KMC group demonstrated be er weight gain a er the fi rst week of life (15.9+4.5 gm/day and 10.6+4.5 gm/day in the KMC group and control group respec vely, p<0.05) 15  In contrast to those studies, in our study average dura on of hospital stay was longer in KMC than control, 16.13 ± 5.8 days in KMC and 13.14±7.6 days in control (p= 0.015). In KMC group weight at enrollment was less (1362.3±240.14 gm) as compared to control group (1415±174.91 gm) but it was not sta s cally signifi cant in mul variate analysis. Longer hospital stay in KMC group may be because of our criteria for discharge in LBW babies which is weight of more than 1.6 kg at discharge.  16 . In a study done by Rao et.al dura on of hospital stay was similar in both groups (12.78±6.2 days in KMC and 12.86±5.7 days in control (P 0.93) which showed that KMC has no eff ect on dura on of hospital stay 14 .
A study done at Rohtak,India by Geeta et al showed that the dura on of hospital stay was signifi cantly shorter in the KMC group (3.56±0.57 days) compared to control group (6.80±1.30 days) 11 . Among KMC group 23 babies (36.5%) developed neonatal hyperbilirubinemia requiring phototherapy. They were temporarily withdrawn from KMC and again included when off phototherapy.
No mortality occurred in both the groups because sick babies were excluded from the study at beginning.

Conclusions
LBW babies weighing less than 2000 gm who receive KMC show be er weight gain than those who do not receive KMC and the incidence of hypothermia in LBW babies weighing less than 2000 gm who receive KMC is less than those who do not receive KMC.