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Keywords
Kangaroo mother care, Long-term followup, Low
birth weight infants, Randomized controlled trial,
Resource-limited country
Correspondence
Takeo Nakayama, M.D., Ph.D., Department of Health
Informatics, Kyoto University, School of Public
Health, Yoshidakonoe Sakyo, Kyoto 606-8501,
Japan.
Tel: +81-75-753-4488 |
Fax: +81-75-753-4497 |
Email: nakayama.t@at2.ecs.kyoto-u.ac.jp
Received
6 February 2011; revised 23 May 2011;
accepted 30 May 2011.
DOI:10.1111/j.1651-2227.2011.02372.x
ABSTRACT
Aim: To examine the long-term effects of earlier initiated continuous Kangaroo
Mother Care (KMC) for relatively stable low-birth-weight (LBW) infants in a resource-limited
country.
Methods: A randomized controlled trial with long-term follow-up was performed in
LBW infants in Madagascar. Earlier continuous KMC (intervention group) was initiated as
soon as possible within 24 h postbirth, and later continuous KMC (control group: conventional care) was initiated after complete stabilization. Outcome measures were mortality or
readmission, nutritional indicators at 612 months postbirth and feeding condition at
6 months postbirth (ClinicalTrials.gov, NCT00531492).
Results: A total of 72 infants were followed for mortality or readmission at 612
months postbirth. There was no difference between the two groups (7 36 vs. 7 36, Risk
ratio (RR), 1.00; 95% CIs, 0.392.56; p = 1.00). The proportion of exclusive breast feeding (EBF) at 6 months postbirth was significantly higher with earlier KMC than later KMC
(12 29 vs. 4 26; RR 2.69; 95% CIs, 1.007.31; p = 0.04). There were no differences in
nutritional indicators between the two groups at 612 months postbirth.
Conclusion: Earlier initiated continuous KMC results in a significantly higher proportion of EBF at 6 months postbirth. Further larger-scale long-term evaluations of earlier
initiated continuous KMC for LBW infants are needed.
INTRODUCTION
Kangaroo Mother Care (KMC) is an important postnatal
intervention for low-birth-weight (LBW) infants in
resource-limited settings. KMC, which is defined by continuous skin-to-skin contact (SSC) between the infant and
mother to prevent hypothermia, promote breastfeeding and
strengthen motherinfant bonding, has been performed on
LBW infants for more than 30 years as a complement to
incubator care (1,2). KMC is listed as one of the five most
efficient interventions in postnatal care in resource-limited
settings (3). Despite its widespread use, KMC had not been
reported to have a conclusive effect on mortality, and evidence was limited to recommend its routine use for LBW
infants (4). A recent updated review, which discussed 12
additional trials and more data from individual studies,
reported the use of KMC in stabilized LBW infants as an
alternative to conventional neonatal care mainly in
resource-limited settings (5). In some of these trials, however, KMC was commenced several days postbirth.
Because 2545% of neonatal deaths occur within 24 h
postbirth (6), interventions must be initiated as soon as
possible.
Key notes
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Nagai et al.
METHODS
Study design
Infants born at the University Hospital of Mahajanga,
Madagascar were assessed for eligibility to participate in
the trial. Eligibility criteria were (i) birth weight under
2500 g, (ii) less than 24 h postbirth, (iii) no serious malformation, (iv) relatively stable clinical condition (oxygen saturation, 95% or more; heart rate, >100 beats per minute;
respiratory rate, <60 times per minute; capillary refilling
time, <3 sec), (v) mother and other family members were
willing to practise KMC and (vi) mother and or family
willing to practise KMC were healthy. Exclusion criteria
were (i) prolonged apnoea (more than 20 sec) and (ii)
intravenous infusion.
If an infant satisfied all eligibility criteria, we obtained
written informed consent from the mother and or father at
the time of enrolment in the study. After obtaining a signature for consent, randomized allocation was carried out
using the minimization method with Minim software. The
prescribed sample size at the beginning of the trial or the
number of infants that may be registered in the trial in
1 year was 100 infants. The sample size was based on an
effect size of 5 in risk ratio (RR) and estimated mortality of
25% in the control group. Details on exclusion criteria, randomization procedures and short-term outcomes have been
reported previously (8).
A total of 73 infants were enroled from August 2007 to
August 2008 and randomly assigned to two groups. The earlier initiated continuous KMC group was instructed to begin
KMC as soon as possible within 24 h postbirth. KMC was
defined as direct and continuous SSC (without any underwear except for a diaper, a warm hat and socks for the
infant) for as long as possible. The later continuous KMC
group initially followed conventional care. Hospital staff
used an incubator or radiant warmer first, and they later
covered the infants with cotton cloth and laid them beside
their mothers in the same bed, but without SSC. KMC was
initiated when the infant and mothers families were completely settled and ready, which was approximately 24 h
postbirth or later. After initiating KMC, all participants were
encouraged by hospital staff to continue KMC for as long as
possible during hospitalization and after discharge. Other
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family members occasionally assisted the mother in performing continuous KMC. In our previous study, participants were followed until 28 days postbirth (8). For this
long-term follow-up study, we observed these participants
until 612 months postbirth (i.e. from September 2008 to
March 2009).
The protocol for this follow-up study was approved by
the Institutional Ethics Committee of the Ministry of Health
in Madagascar and the Research Ethics Board of Kyoto
University in Japan. After approving, the registration of
ClinicalTrials.gov was revised (number NCT00531492).
Outcomes
The primary outcome was mortality or readmission at 6
12 months postbirth (i.e. from 1 week before 6 months
postbirth to 1 week after 12 months postbirth). Readmission was surrogated for morbidity during the trial period.
Data were collected from hospital charts, maternal and
child health handbooks and family interviews at 6
12 months postbirth. Secondary outcomes were (i) feeding
status at 6 months postbirth and (ii) nutritional indicators
at 612 months postbirth. For feeding status, we ensured
exclusive breastfeeding (EBF), in which the infant received
only breast milk and nothing else. Medicine, oral rehydration solution, vitamins and minerals, as recommended by
health providers, were allowed during EBF (9). Nutritional
indicators were assessed by (i) stunting (measured by
height-for-age), (ii) wasting (measured by weight-for-height)
and (iii) underweight (measured by weight-for-age). We followed the World Health Organization (WHO) child growth
standards (10) and the growth standards of Madagascar
(11). WHO Anthro 2005 software (WHO, Geneva, Switzerland, http://www.who.int/childgrowth/software/en/) was
used for calculating the Z-score of each indicator. The cutoff point for malnutrition was a Z-score < )2, and severe
malnutrition corresponded to a Z-score < )3 (12). The
growth standard of Madagascar is used for rapid assessment
of acute malnutrition screening, which is based on the
National Center for Health Statistics growth reference (13).
This standard only observes wasting. The cutoff point for
malnutrition was <75%, and severe malnutrition corresponded to <60% (11).
Data collection
Data were collected daily by a research coordinator through
interviews with mother family and from medical records
during hospitalization. To observe health conditions at 6
12 months postbirth, another research coordinator visited
all participants at home. If the family was absent at the
appointed time, the research coordinator visited repeatedly
until a meeting with the infant and mother family was
achieved, and the participants information (health status,
measurements of weight and height) was collected. If the
family relocated outside the follow-up area, the research
coordinator telephoned the family and or visited a relatives
house and obtained the participants information (health
status). The research coordinator was blinded to participant
allocation.
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Nagai et al.
Statistical analysis
Participant baseline characteristics and outcomes are
reported through means and standard deviation (SD), frequency and percentage for comparison between the two
groups. Fishers exact test was used for binary comparisons,
and analysis of variance was used to compare continuous
data. RR and 95% confidence intervals (95% CIs) were used
to compare incidences in primary and secondary outcomes
between the two groups. Adjusted analyses were conducted
with birth weights, Apgar score, gender for EBF at 6 months
postbirth and nutritional indicators at 612 months postbirth in secondary outcomes using a logistic regression
model. Nonparametric analysis by Wilcoxon rank-sum test
was conducted for distribution of nutritional indicators
(Z-score of WHO child growth standard, percentage of the
growth standards of Madagascar). The two-sided level of
significance was set at p < 0.05. JMP software version 6.0
RESULTS
Study participants
The number of infants who were screened, randomly
assigned to earlier or later continuous KMC and assessed at
612 months postbirth are shown in Figure 1. Follow-up
assessments began in September 2008 and ended in March
2009. One infant was lost to follow-up because the family
relocated and could not be contacted by telephone, and
neighbours had no information on their whereabouts. Adequate data for analysis of the primary outcome were available for 72 (98.6%) infants. Thirty-one infants (42.5%)
relocated from where they had lived at birth at least once
during the 612 months postbirth. Of these, 17 were
37 were assigned to
earlier KMC group
36 were assigned to
later KMC group
1 loss to follow-up
2 dead
5 moved to outside
study follow-up area
2 dead
8 moved to outside
study follow-up area
2011 The Author(s)/Acta Pdiatrica 2011 Foundation Acta Pdiatrica 2011 100, pp. e241e247
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Nagai et al.
Later KMC
group (N = 26)
2074.3 (297.9)
12 (46.2)
14 (53.8)
36.0 (2.07)
3 (11.5)
11 (42.3)
12 (46.2)
13 (50.0)
1 (3.9)
3 (11.5)
9 (34.6)
19 (73.1)
20 (76.9)
6 (23.1)
1 (3.9)
25 (96.1)
11 (42.3)
15 (57.7)
followed to their new house by contacting the family by telephone and or by asking the neighbourhood. Information
for 13 infants could only be obtained by telephone as the
family had relocated outside the follow-up area; only the
primary outcome was analyzed for these infants.
Primary outcome
Mortality or readmission to 612 months postbirth
Mortality
Readmission
Secondary outcomes
Exclusive breastfeeding at 6 months postbirth
Nutritional indicators at 612 months postbirth
Stunting* (Zscore < )2)
Severe stunting* (Zscore < )3)
Wasting* (Zscore < )2)
Severe wasting* (Zscore < )3)
Underweight* (Zscore < )2)
Severe underweight* (Zscore < )3)
Earlier KMC
group Incidence (%)
N = 36
7 (19.4)
2 (5.6)
5 (13.9)
N = 29
12 (41.4)
N = 36
7 (19.4)
2 (5.6)
5 (13.9)
N = 26
4 (15.4)
12 (41.4)
3 (10.3)
0 (0.0)
0 (0.0)
6 (20.6)
1 (3.4)
13 (50.0)
4 (15.4)
4 (15.4)
0 (0.0)
11 (42.3)
4 (15.4)
Risk ratio
(95% CIs)
p-value adjusted
p-value**
1.00 (0.392.56)
1.00 (0.156.72)
1.00 (0.323.16)
1.00
1.00
1.00
2.69 (1.007.31)
0.04 0.04
0.83 (0.461.48)
0.67 (0.172.73)
0.49 (0.211.14)
0.22 (0.031.88)
0.59 0.78
0.70 0.79
0.14 0.15
0.18 ***
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2011 The Author(s)/Acta Pdiatrica 2011 Foundation Acta Pdiatrica 2011 100, pp. e241e247
Nagai et al.
14
12
p = 0.49*
12
p = 0.004*
10
10
2
0
(n) 4
3
2
(Z-score)
0
(n) 4
3
2
(Z-score)
(Stunting: height-for-age)
(Wasting: weight-for-height)
12
25
p = 0.04*
10
p = 0.008*
20
15
6
10
2
(n) 4
3
(Z-score)
0
2
60
70
75
80
85
100
(%)
//
(n)
(Wasting: weight-for-height)
Figure 2 Distribution of nutritional indicators. (A) WHO Child Growth standard (Stunting: height-for-age). (B) WHO Child Growth standard (Wasting: weight-for-height).
(C) WHO Child Growth standard (Underweight: weight-for-age). (D) Growth standard in Madagascar (Wasting: weight-for-height).
DISCUSSION
We performed this randomized controlled trial with followup to examine the long-term effects of earlier initiated continuous KMC on relatively stable LBW infants in a
resource-limited setting. Although our results indicate that
2011 The Author(s)/Acta Pdiatrica 2011 Foundation Acta Pdiatrica 2011 100, pp. e241e247
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Nagai et al.
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5 years of age (22,23). The potential effects of earlier initiated continuous KMC are expected to be greater in
resource-limited settings. However, earlier initiated continuous KMC is not always applicable to all infants. For
instance, in our study, 48.3% (113 234) of LBW infants
were excluded because they were in unstable condition or
the familys conditions (mother and other family members
were willing to practise KMC and mother and or other
family willing to practise KMC were healthy) were not
available within 24 h postbirth (Fig. 1) (8). Additional
studies will be needed to examine the potential role of
earlier initiated postbirth interventions.
One potential limitation of the study was the earlier and
continuous interventions. Prior to this study, continuous
KMC was conventionally initiated approximately 4872 h
postbirth at the University Hospital of Mahajanga, Madagascar. Indeed, in the trial, only an 11 h difference exists
between initiating earlier and later continuous KMC, and
there was overlap between the intervention and control
group with respect to time of KMC onset. Because KMC
was officially introduced to Madagascar in 2000 (24), we
could not include a no KMC group as a control. In addition, the sample size was not large enough to show the
effects on outcomes, and the proportion of events was lower
to compare with the estimation before the trial. Another
reason for the reduced number of participants in this longterm follow-up study was that 31 infants (31 73, 42.5%)
had relocated between birth and 612 months postbirth.
Some families moved 23 times during this period, and they
occasionally moved to another town to look for employment. The frequency of address changes was much higher
than we anticipated.
The overall effects of earlier initiated SSC and KMC
targeting preterm LBW infants are still inconclusive even
in developed countries (25,26). In our study, we followed
only outcomes such as mortality, readmission, EBF and
nutritional indicators, but earlier initiated SSC and KMC
might have effects on other outcomes (e.g. mother-preterm infant interaction, reduction of maltreatment, infants
cognitive and or motor-development). Accordingly, evaluation of other outcomes will likely be informative. The
effects of the timing and or duration of intervention were
also insufficient. Recently, a prospective longitudinal study
from a developed country showed that the time spent in
KMC (duration of KMC per day) in the hospital is associated with breastfeeding duration in very preterm infants
(27). Furthermore, much longer follow-up outcomes
would be informative, in particular, with respect to EBF
(28).
CONCLUSION
Earlier initiated continuous KMC for relatively stable
LBW infants in a resource-limited country results in a significantly higher proportion of EBF at 6 months postbirth.
Further adequately designed, larger-scale long-term evaluations of earlier continuous KMC for LBW infants are
needed.
2011 The Author(s)/Acta Pdiatrica 2011 Foundation Acta Pdiatrica 2011 100, pp. e241e247
Nagai et al.
ACKNOWLEDGEMENTS
We thank research coordinators: A. Ramarijaona and M.E.
Raza-Fanomezanjanahary, head nurse;H.N. Ralibenja and
all the staff members in the neonatal unit at the University
Hospital of Mahajanga for their assistance, the president of
the KMC association in Madagascar;Y. Ranaivoson for her
KMC technical advice, and, most importantly, all the participants of this study. In addition, we thank anonymous
reviewers and the editor of Acta Paediatrica to their useful
comments. This study was supported by grants from FASID:
Foundation for Advanced Studies on International Development and St. Lukes Life Science Institute, Japan.
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