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Effect of early skin-to-skin contact following normal delivery on incidence of hypothermia in neonates more than 1800 g: randomized control trial

Subjects

Abstract

Objective:

To investigate the impact of early skin-to-skin contact (SSC) provided for first 24 h on incidence of hypothermia in stable newborns weighing 1800 g or more during first 48 h of life.

Study Design:

Stable newborns (term and late preterm: Mean gestational age 37.7 (1.35) weeks, range 34–40 weeks) having birth weight 1800 g or more (Mean weight 2605.6 (419.8) grams) were enrolled after approval from Institutional Human Research Ethics Committee (CTRI/2013/06/003790) and randomized into early SSC (intervention group) and conventional care (control group). Initial care in the delivery room for few minutes immediately after birth in both the groups was given under radiant warmer. In the intervention group, newborns were provided SSC by their mother started between 30 min and 1 h after birth for first 24 h with minimal interruption and were provided conventional care other than SSC for next 24 h of life. In the control group, newborns were kept with their mother and received conventional care other than SSC for first 48 h. Temperature and heart rate of newborns were recorded at 30 min, 1, 2, 3, 4, 5, 6, 12, 24 and at 48 h of life in both the groups. Independent Samples t-Test and relative risk were used to analyze the data.

Result:

Both groups had 50 neonates each with similar baseline characteristics. Heart rates were in normal range in both the groups. The intervention group provided an average (s.d.) of 16.98 (0.28) h of SSC over the first 24 h period. The mean temperature was significantly high in the SSC group at all time intervals starting from 1 to 48 h (P<0.05 for all). In the SSC group only two newborns (4%) had mild hypothermia (cold stress), and, of these two newborns, one had two episodes of hypothermia. All these three episodes of hypothermia occurred within first 3 h of life. In the control group 16 newborns (32%) developed hypothermia (temperature<36.5 °C) during first 48 h of life. Of them, 11 newborns had single episode, 4 newborns had two episodes and one newborn had three episodes of hypothermia. Of these 22 hypothermic episodes, 20 occurred in the first 6 h of life and 2 episodes occurred at 48 h of life. Moderate hypothermia was seen in two newborns, whereas rest had mild hypothermia. The relative risk of developing hypothermia in the control group as compared with the SSC group was 8.00 (95% CI 1.94–32.99). There was no seasonal variation in incidence of hypothermia in both the groups.

Conclusion:

Newborns in the SSC group achieved rapid thermal control as compared with the control group. Early SSC for 24 h after birth decreases incidence of hypothermia for initial 48 h of life. Early SSC needs to be aggressively promoted in term and late-preterm newborns to reduce incidence of hypothermia.

Introduction

Maintenance of infant’s neutral temperature requires understanding of various mechanisms influencing heat loss in newborn, and maintaining neutral temperature has an important role in improving the neonatal outcome.1 Practices such as keeping baby unattended, bathing immediately after birth, delayed drying and wrapping put the baby at an additional risk for heat loss.2 Fetus maintains about 0.5 °C temperature higher than that of the mother due to heat production by its tissues.3 At birth, the newborn is exposed to relatively cold environment and various mechanisms cause the temperature to drop rapidly.4 On an average, the temperature drops by 2–4 °C in the first few minutes after birth and even greater fall can occur in the absence of adequate thermal protection.5 The main mechanism contributing to the heat production in newborn is nonshivering thermogenesis.1 However, in a cool environment thermogenic response is limited during first 12 h of life. This necessitates adoption of measures and practices to limit heat loss during this period.6

World Health Organization (WHO) defines hypothermia as present when the newborn’s axillary temperature falls below 36.5 °C.7 Hypothermia leads to adverse neonatal outcomes like impaired growth, hypoglycemia, generalized internal bleeding, and increased risk of infection, metabolic acidosis, respiratory distress and even death.7

Kangaroo mother care (KMC) in the management of low birth weight (LBW) newborns was pioneered in 1978 in Colombia and it incorporates skin-to-skin contact (SSC), frequent and exclusive, or nearly exclusive breastfeeding and early discharge from hospital.8 In the beginning, KMC represented an appropriate use of scarce resources in low-income countries.9 Effective thermal control is achieved with reduced risk of hypothermia by SSC.10 Rewarming of hypothermic neonates in SSC position is at least as effective as an incubator.11 Mori et al.12 in their meta-analysis concluded that in low middle income settings SSC is effective in increasing the body temperature of newborns by 0.22 °C. SSC has been as effective as radiant warmers in preventing heat loss in healthy full-term infants.13 Early SSC involves placing naked baby prone on mother’s bare chest at birth or soon afterward. Early SSC for term or late-preterm infants can be divided in to birth SSC (during the first minute post birth), very early SSC (beginning 30–40 min post birth) and early SSC (anytime between 1 and 24 h post birth).13

Studies on incidence of hypothermia in newborns in limited resource countries like India are based on single axillary temperature reading within first 24 h of birth at home using varying case definitions.14, 15 Kumar et al.14 in their study from Haryana, North India considered hypothermia present when axillary temperature <35.6 °C and reported its incidence to be 11.1%. Darmstadt et al.15 in their study from Uttar Pradesh, North India defined it when axillary temperature <36.5 °C and reported its incidence to be 45%. In both of these studies, authors did not stratify the severity of hypothermia. In Gadchiroli, Western India, Bang et al.16 recorded the temperature at home and demonstrated incidence of hypothermia (axillary temperature<35 °C) to be 17%. Christensson et al.17 from Sweden and Marín Gabriel et al.18 from Spain studied influence of early SSC for initial first few hours of life and found SSC to be beneficial in thermal stability.

According to the past records in our hospital, incidence of hypothermia is around 40% including term and late-preterm newborns, indicating need of low-cost intervention that can reduce the incidence of hypothermia. To address this issue and to overcome deficiencies mentioned in previous studies in India, this study was undertaken to evaluate the effect of early SSC for first 24 h on incidence of hypothermia based on standard WHO definition in term and late-preterm newborns.

Methods

Study design

Superiority Randomized Control Trial (CTRI/2013/06/003790). Randomization was done based on web based software (WINPEPI) and selection cards were sealed in the opaque envelopes.

Study site

This study was conducted at Maternity ward of Shree Krishna Hospital (SKH) attached to Pramukhswami Medical College, Karamsad from Anand district of Gujarat, North India over a period of 10 months from June 2012 to March 2013.

As a routine policy, before 20 min of expected time of delivery, open care servo-controlled radiant warmer is switched on to full heater output on manual mode and blankets are kept under it to make them warm and temperature of delivery room newborn care corner is maintained above 25 °C. All the newborns delivered at delivery room are immediately taken under the radiant warmer, dried immediately and then wet blankets are removed and covered with fresh warm blankets. This policy is different from the WHO recommendations of keeping the newborn on mother’s bare chest immediately after birth. Before transporting newborns to maternity ward with their mothers, they are clothed and cap is applied. Maternity wards are not climate controlled like the delivery room. Temperature of maternity ward was recorded with room temperature monitor at 12 h interval in the noon and midnight when the temperature differences are highest.

As per the protocol, stable newborns weighing 1800 g are provided level I care in maternity ward with their mothers. Rest of the newborns are cared at the attached level II neonatal intensive care unit (NICU) accredited by National Neonatology Forum of India. Being a tertiary care referral center, rates of premature (20–25%) and LBW (40–45%) deliveries in SKH are high. All the staff nurses are formally trained in the implementation of KMC for LBW newborns during induction training and regular biyearly updates. KMC has been a standard of care for more than 10 years to physiologically stable LBW newborns in maternity ward and NICU. Early SSC for term newborns was not implemented before this study.

Study population

Stable newborns with birth weight 1800 g or more and delivered vaginally were eligible to participate in this study. Newborns were excluded if delivered by cesarean section, needed any resuscitation measures or were detected to have any congenital malformation at birth. Practice of KMC was continued for the LBW newborns not enrolled in the study. To prevent contamination of KMC in the enrolled newborns, two strategies were employed: (i) the enrolled newborns’ treatment record files were labelled ‘Follow the study protocol: intervention/control’ and (ii) in the daily treatment advise form of the newborns, ‘Instructions to be followed as per study protocol: intervention/control’ was mentioned.

Sample size

According to the past records, incidence of hypothermia is roughly 40% in our hospital. An absolute drop of 25% in the incidence was considered clinically important. Considering alpha (type I error) at 5%, 47 neonates were required in each group to achieve a power of 80%. Drop outs were not expected because of the study design, and hence 100 participants were recruited in the study (50 per group).

Study procedure

Newborns fulfilling inclusion criteria were included in the study after taking informed consent from their mother (that is, after their immediate post delivery care is over by around 15 to 20 min of birth) and randomized in two groups either to receive (a) early SSC (intervention group) or (b) conventional care (control group).

In the intervention group, mothers were explained immaculately about the procedure of SSC by the nurses/resident doctor working in the maternity ward. Mothers were provided clothing in the form of front open gowns with short sleeves and were advised to start SSC at 30 min to 1 h after delivery and continue for as long as possible in the first 24 h with each session lasting for minimum 60 min. SSC was discontinued after 24 h. In the control group, after providing routine care under radiant warmer, newborns were kept clothed (including head cap) and covered with blanket with their mother (bedding in) for first 48 h. In both the groups newborns were exclusively breast fed.

Temperature and heart rate in the SSC group (irrespective of whether SSC was ongoing or not) and in the control group were recorded first at 30 min and subsequently at 1, 2, 3, 4, 5, 6, 12, 24 and 48 h of life. Axillary temperature was recorded with a Smart Care–Digital Thermometer (SCT01), and pulse rate was monitored by pulse Oximeter of L&T medical (Model- L&T/STELLAR). Order of recording parameters was pulse rate from monitor followed by axillary temperature to avoid physical effect on pulse rate during temperature recording. WHO definition of hypothermia was followed in this study.

Statistical analysis

Descriptive statistics were used to depict the characteristics of the study population. The difference in the mean temperature between the two groups at different time points was assessed using Independent Samples t-Test. The overall trend in the mean temperatures of the two groups was portrayed using a line diagram. Relative risk (RR) was used to estimate the effect of SSC on the incidence of hypothermia. χ2 test was used to assess association between incidence of hypothermia and season. Data were entered using Microsoft Office Excel 2010 and imported to SPSS 14 (SPSS Inc, Chicago, IL, USA) for analysis after validation and cleaning.

Ethical considerations

The study was approved by human research ethics committee of HM Patel Centre for Medical Care and Education, Karamsad.

Results

Out of the 232 consecutive newborns assessed for eligibility, 132 newborns were excluded. Thus, 50 participants were recruited in each group (Figure 1). The mean (s.d.) baseline heart rate was 140.95 (7.28) (range: 128 to 159 min) and mean (s.d.) baseline temperature was 36.88 (0.25) (Range: 36.6 to 37.6 °C). Other clinical characteristics of the two groups were similar at the baseline (Table 1).

Figure 1
figure1

Flow of recruitment of study participants.

Table 1 Baseline characteristics of the study population

The mean (s.d.) time to start SSC in the intervention group was 43 (12.5) minutes after birth. The mean (s.d.) time of SSC was 16.98 (0.28) (range: 16.5 to 17.5 h) during the first 24 h.

Among controls, 16 (32%) newborns developed hypothermia (temperature<36.5 °C) during the initial 48 h of life. Of these 16 newborns, 10 (62.5%) were LBW, whereas 5 (31.2%) were late preterm. All these 16 newborns became hypothermic within first 6 h of life, and, of these, two newborns (both were LBW as well as preterm) also had repeat episode of hypothermia at 48 h of life. Eleven newborns had a single episode of hypothermia, four newborns had two episodes of hypothermia and one newborn had three episodes of hypothermia adding to 22 episodes of hypothermia in first 48 h of life. Out of these five newborns with multiple episodes of hypothermia, four were LBW and three were preterm. Moderate hypothermia was seen in two newborns, whereas rest had mild hypothermia.

In the SSC group only 2 (4%) newborns developed hypothermia, and, of these, one newborn had two episodes of hypothermia. Both newborns had mild hypothermia (cold stress). In two newborns in the SSC group who had hypothermia, one newborn was LBW and preterm. The newborn with repeat episode of hypothermia was a term neonate and had these at the first and third hour of life. No newborn in the SSC group had hypothermia after 3 h of life.

The mean temperature was significantly higher in the SSC group as compared with the control group at all the time intervals starting from 1 to 48 h (P<0.05) (Figure 2). The relative risk of developing hypothermia in the control group was eight times higher (95% CI 1.94–32.99) as compared with the SSC group (Table 2).

Figure 2
figure2

Mean temperature at various time intervals after birth in both the groups. P-value suggests difference between means of two groups at respective time.

Table 2 Hypothermia and group status (n=100)

This study covered 2 months of summer (March and June), 4 months of monsoon (July to October) and 4 months of winter (November to February). It did not include the warmest period of the year (May) but included the coolest period of the year (January). The low average during March and June to October varied from 21 to 27 °C, whereas in the cooler months varied from 12 to 19 °C. The high averages during the same periods were 32 to 38 °C and 28 to 36 °C, respectively. In the SSC group 1 (7.7%) of 13 newborns, 1 (3.8%) of 26 newborns and none of 11 newborns developed hypothermia in summer, monsoon and winter, respectively (P=0.631). In the control group 2 (25%) of 8 newborns, 5 (26.3%) of 19 newborns and 9 (39.1%) of 23 newborns developed hypothermia in summer, monsoon and winter, respectively (P=0.607). Thus, season was not associated with hypothermia in both the groups in the present study.

Discussion

The study revealed that the incidence of hypothermia in conventional care was significantly higher as compared with the SSC (32% vs 4%, P<0.001). Marín Gabriel et al.18 estimated influence of SSC on thermal regulation in term and nearly term newborns after giving 2 h of continuous SSC immediately after birth and found an average temperature rise of 0.07 °C more as compared with the control group newborns who were wrapped with a warm blanket and then given back to their parents, but they did not report any changes in axillary temperature at 5 min and at 2 h of birth in both the groups. In the present study, we found significantly higher temperature in the SSC group at each time interval starting from 1 to 48 h. In a study of full-term newborns during first 90 min of life by Christensson et al.,17 axillary and the skin temperatures were significantly higher in the SSC group as compared with newborns kept next to their mother in a cot. In another study, Christensson et al.17 concluded that STS care was at least as effective as incubator care for rewarming low-risk hypothermic infants (clinically stable with admission weight of 1500 g).11

In the present study, 16 (32%) neonates developed hypothermia within first 48 h of life in the control group that is comparable to the 40% incidence of hypothermia during hospital stay from the past records as in this study we have not incorporated the findings after 48 h of life. All these 16 newborns developed hypothermia within first 24 h of life. Kumar et al.2 also reported that the majority of the hypothermia episodes occur in first day of life.

A discussion of the general environmental temperature is imperative as the maternity wards are not climate controlled and the temperatures do vary with the incumbent weather in the region during winter, summer and rainy seasons and this is applicable to most of the states of India. These vagaries of nature have also been explained by Bang et al.16 and concluded that incidence of hypothermia was higher in winter months without home-based neonatal care in preintervention period, whereas there was no significant difference in incidence of hypothermia based on season in post intervention period. However, study from Nepal with lower environmental temperature showed significantly higher incidence of hypothermia in winter season, but they have not mentioned about the practices followed to keep the newborns warm.19 Thus, SSC is an intervention for term and late-preterm newborns that can work in all seasons across India without using additional resources in terms of electricity, which is often unavailable.

Several studies have shown that SSC is helpful in maintaining neutral thermal environment. Bystrova et al.20 observed the temperature every 15 min in the axilla, on the thigh, back and foot during 30 to 120 min of life in SSC and nursery group (newborns were clothed and kept in the nursery) and found significant lower temperature in the nursery group along with significant increase in temperature over time in the SSC group. Bergman et al.21 compared SSC with conventional incubator care in newborn of 1200 to 2199 g to see the physiological stabilization for first 6 h of life. Temperature as well as cardio-respiratory stabilization score was higher in the SSC group compared with conventional incubator care.

Our study results are consistent with these studies, and the mean temperature in the SSC group was higher compared with the control group at all stages of reading during first 48 h of life. Temperature of newborns in SSC groups progressively increased after birth, whereas in the control group there was reduction in temperature at1 h of birth and never matched with the SSC group for first 48 h. This study also showed that early SSC for first 24 h can reduce risk of hypothermia at 48 h of life. In a large hospital-based study from NICU at Mumbai, Western India, Rao et al.22 reported 36.9% incidence of hypothermia in control arm as compared with 5.9% in the SSC group. In this study, the average age of enrollment in the intervention group was 3.7±2.8 days, suggesting that few newborns received SSC on the first day of life and did not address the prevention of hypothermia on the first day of life. The present study adds to this knowledge base and provides information of effect of early SSC on incidence of hypothermia within first 48 h of life.

Hypothermia is an independent predictor of neonatal mortality and is additionally closely associated with many other factor like sepsis, prematurity and birth asphyxia that are major causes of neonatal mortality.23 Lunze et al.23 in systematic review reported the case fatality for neonatal hypothermia ranged from 8.5 to 52%. In a study from Nepal, the relative risk of death ranged from 2 to 30 times within the WHO classification for moderate hypothermia and increased with greater severity of hypothermia.24 These observed risks of neonatal hypothermia for neonatal mortality emphasize the importance of temperature control and prevention of hypothermia in newborn. In the current study, the proportion of neonates developing hypothermia was eight times higher in conventional care compared with the SSC group. Hence, the reduced risk of hypothermia will translate to an improvement in neonatal outcomes. Our study is hospital based, yet it is generalizable to the context of low resource countries as the environments are similar. Community-based study is also warranted as many local beliefs and behaviors like early bathing, delayed drying and wrapping may increase the risk of hypothermia and interfere with implementing simple steps of hypothermia prevention.23

In today’s world, majority of newborns including preterm are born in lower and lower middle income counties without the availability of incubator or radiant warmer care. Many neonates succumb before stabilization and acclimatization to environments before the first 3 days of life. SSC is an alternative to an incubator and radiant warmer in reducing heat loss in stable newborns. Even where such resources are available it may be the better alternative due to possible neuro-developmental benefits. As early SSC reduces incidence of hypothermia in newborns within first 48 h of life, it can contribute in reduction of neonatal mortality due to hypothermia.

Conclusion

Newborns in the SSC group achieved rapid thermal control and maintained it as compared with the control group, thus emphasizing the importance of early SSC on prevention of hypothermia during first 48 h of life. The risk of hypothermia was significantly high in the term and late-preterm newborns cared on cot with mother compared with SSC care. Early SSC for 24 h reduced hypothermia in newborns even for the next 24 h when not given. Early SSC needs to be aggressively promoted to prevent hypothermia in term and late-preterm newborns.

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Nimbalkar, S., Patel, V., Patel, D. et al. Effect of early skin-to-skin contact following normal delivery on incidence of hypothermia in neonates more than 1800 g: randomized control trial. J Perinatol 34, 364–368 (2014). https://doi.org/10.1038/jp.2014.15

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Keywords

  • skin-to-skin care
  • hypothermia
  • thermal control
  • neonates

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