| Literature DB >> 34038632 |
Sugandha Arya1, Helga Naburi1, Kondwani Kawaza1, Sam Newton1, Chineme H Anyabolu1, Nils Bergman1, Suman P N Rao1, Pratima Mittal1, Evelyne Assenga1, Luis Gadama1, Roderick Larsen-Reindorf1, Oluwafemi Kuti1, Agnes Linnér1, Sachiyo Yoshida1, Nidhi Chopra1, Matilda Ngarina1, Ausbert T Msusa1, Adwoa Boakye-Yiadom1, Bankole P Kuti1, Barak Morgan1, Nicole Minckas1, Jyotsna Suri1, Robert Moshiro1, Vincent Samuel1, Naana Wireko-Brobby1, Siren Rettedal1, Harsh V Jaiswal1, M Jeeva Sankar1, Isaac Nyanor1, Hiresh Tiwary1, Pratima Anand1, Alexander A Manu1, Kashika Nagpal1, Daniel Ansong1, Isha Saini1, Kailash C Aggarwal1, Nitya Wadhwa1, Rajiv Bahl1, Bjorn Westrup1, Ebunoluwa A Adejuyigbe1, Gyikua Plange-Rhule1, Queen Dube1, Harish Chellani1, Augustine Massawe1.
Abstract
BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain.Entities:
Mesh:
Year: 2021 PMID: 34038632 PMCID: PMC8108485 DOI: 10.1056/NEJMoa2026486
Source DB: PubMed Journal: N Engl J Med ISSN: 0028-4793 Impact factor: 91.245
Figure 1.Participants flowchart
Baseline characteristics of randomized infants, mothers and households
| Immediate Kangaroo Mother Care | Control | |
|---|---|---|
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| Age at randomization in minutes (median, IQR) | 35 (20,55) | 33 (20,54) |
| Birth weight in kg, mean (SD) | 1.5 (0.2) | 1.5 (0.2) |
| Gestational age at birth, mean (SD) | 32.6 (3.0) | 32.6 (2.8) |
| Male, n (%) | 752 (46.7) | 748 (46.7) |
| Infants born as twin, n (%) | 430 (26.7) | 430 (26.8) |
| Delivery by C-section n (%) | 559 (34.7) | 614 (38.3) |
| Site, n (%) | ||
| Ghana | 205 (12.7) | 205 (12.8) |
| India | 695 (43.2) | 682 (42.6) |
| Malawi | 217 (13.5) | 222 (13.9) |
| Nigeria | 108 (6.7) | 107 (6.7) |
| Tanzania | 384 (23.9) | 386 (24.1) |
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|
|
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| Mother’s age in years, mean (SD) | 26.7 (5.8) | 26.7 (5.8) |
| Mother's years of schooling, median (IQR) | 10 (7,12) | 10 (7,12) |
| Family income in US dollars, median (IQR) | 168 (110,285) | 176 (110,280) |
| Piped water as main source of drinking water,n (%) | 934 (63.5) | 953 (64.7) |
| Households with a toilet in the house, n (%) | 1288 (87.9) | 1343 (91.3) |
There were 534 infants (from 267 mothers) who were born from a multiple pregnancy and both were eligible and enrolled (278 infants in the intervention and 256 infants in the control).
In addition, there were 325 mothers with multiple pregnancies in whom only one of the infants was eligible and the other one was ineligible (152 infants in the intervention group and 173 in the control).
Gestational age based on ultrasound in first or second trimester, and if not available then based on LMP, and if both USG and LMP not available, then based on Ballard score (assessing measures of maturity on examination)[21]
Gestational age at birth missing for 27 infants in intervention and 18 infants in control group
2 households in intervention and 2 in control group have missing data on mother’s education
5 households in intervention and 3 in control group have missing data on availability of toilet Additional baseline characteristics are provided in Table S1
Initiation and duration of skin -to-skin contact in randomized infants
| Immediate Kangaroo Mother Care N=1609 | Control N=1602 | |
|---|---|---|
| Time to initiation of skin-to-skin contact in hours | 1.3 (0.8–2.7) | 53.6 (33.8–101.4) |
| Time to initiation of skin-to-skin contact by category, n (%) | ||
| <2 hours | 1098 (68.2%) | 4 (0.2%) |
| 2 to ≤6 hours | 306 (19.0%) | 14 (0.9%) |
| 6 to ≤12 hours | 94 (5.8%) | 14 (0.9%) |
| 12 to ≤24 hours | 62 (3.9%) | 74 (4.6%) |
| 24 to ≤168 hours | 32 (2.0%) | 1176 (73.4%) |
| >168 hours to end of neonatal period | 1 (0.1%) | 142 (8.9%) |
| Never initiated | 16 (1.0%) | 178 (11.1%) |
| Skin-to-skin contact while in NICU, hours per day, median (IQR) | 1609 | 1602 |
| Overall | 16.9 (13.0–19.7) | 1.5 (0.3–3.3) |
| With mother | 12.3 (6.8–16.5) | 1.5 (0.2–3.2) |
| With surrogate | 2.3 (0.1–6.5) | 0 (0–0) |
| Skin-to-skin contact while in Kangaroo Mother Care ward, hours per day, median (IQR) | 1300 | 1224 |
| Overall | 20.2 (18.6–21.3) | 19.0 (16.3–20.4) |
| With mother | 19.4 (14.8–20.6) | 18.0 (14.1–19.9) |
| With surrogate | 0 (0–0.85) | 0 (0–0) |
If the infant never initiated skin-to-skin contact and: (i) died: censored at the time of death (ii) taken home against medical advice or refused consent: censored at time of leaving the hospital or refusing consent, respectively; (iii) was discharged: censored at time of discharge; (iv) was still in hospital at the end of the neonatal period: censored at day 28.
Primary and secondary outcomes in randomized infants
| Immediate Kangaroo Mother Care (1609 assigned) | Control (1602 assigned) | Adjusted RR (95%CI) | P | |
|---|---|---|---|---|
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| Death between enrolment and 28 days of age, n (%) | 191/1596 (12.0%) | 249/1587 (15.7%) | 0.75 (0.64–0.89) | 0.001 |
| Death between enrolment and 72hr of age, n (%) | 74/1606 (4.6%) | 92/1599 (5.8%) | 0.77 (0.58–1.04) | 0.09 |
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| Exclusive breastfeeding at the end of neonatal period, n (%) | 1208/1401 (86.2%) | 1140/1336 (85.3%) | 1.01 (0.98–1.05) | |
| Fully breastfed (only by suckling) at hospital discharge, n (%) | 62/1435 (4.3%) | 55/1376 (4.0%) | 1.06 (0.73–1.53) | |
| Hypothermia, n (%)[ | 90/1609 (5.6%) | 133/1602 (8.3%) | 0.65 (0.51–0.83) | |
| Time to clinical stabilization in hr, median (IQR)
[ | 73.8 (26.8;138.5) (n=1609) | 74.8 (25.3;140.6) (n=1602) | 0.98 (0.90; 1.07) | |
| Suspected sepsis, n (%) [ | 361/1575 (22.9%) | 434/1561 (27.8%) | 0.82 (0.73–0.93) | |
| Hypoglycemia at any time between 0–36h of age, n
(%)[ | 82/799 (10.3%) | 66/651 (10.1%) | 1.15 (0.85–1.56) | |
| Duration of hospital stay in days, mean (SD)[ | 14.9 (0.2) (n=1609) | 15.2 (0.2) (n=1602) | 1.07 (0.99;1.16) | |
| Maternal satisfaction with health care in the hospital,
mean (SD)[ | 9.2 (1.0) (n=1282) | 9.1 (1.2) (n=1233) | 0.11 (0.03–0.19) | |
| Maternal depression, n (%)[ | 2/1276 (0.2%) | 7/1231 (0.6%) | 0.23 (0.05–1.14) |
Any instance of axillary temperature <36ºC at any time from 2 hours after randomization until discharge from hospital.
First time at which the infant had all signs of clinical stability: no need for CPAP, no episodes of apnea, SpO2>90, Respiratory rate 40 to < 60, Heart rate 80 to < 180 bpm, Temperature between 36 to 37.4ºC, and no need for IV fluids.
Suspected sepsis defined as one or more of the following signs/symptoms: temperature<35.5ºC or > 38ºC, no movement or movement only on stimulation, chest indrawing, convulsions. For all the signs/symptoms, we removed the first 24 hours, after that time the child should have been well for at least 24 hours before becoming sick. Denominator excludes infants that died, LAMA or were discharged before 48 hours of age.
Hypoglycemia defined as blood sugar < 45 m/dl or < 2.6 mmol/L measured when clinically indicated
Duration of hospital stay was a pre-specified process outcome
Maternal satisfaction with health care in the hospital was collected at discharge on a score of 1 to 10. Higher score implies higher satisfaction
Maternal depression defined as a score of >15 points on Patient Health Questionnaire 9
adjusted for clustering due to multiple births, site, delivery mode, multiple pregnancy, age at randomization, infant’s sex, infant’s weight, mother's years of schooling, maternal age, households with toilet in the house, and family income.
The 95% confidence intervals for secondary outcomes are not adjusted for multiplicity and should not be used to infer definitive intervention effects.
Hazard ratio
Mean difference
Figure 2.Subgroup analyses of primary outcomes by birthweight, gestational age, multiple pregnancy, mode of delivery and size for gestational age
* 26 infants in the intervention and 18 infants in the control group have their gestational age at birth missing. Size for gestational age could not be calculated for one additional infant that was born with indeterminate sex.
¥ adjusted by site and clustering due to multiple births. For the subgroup analysis by site, adjustment was only done for clustering due to multiple births.
**The widths of the confidence intervals were not adjusted for multiplicity, so the intervals should not be used to infer definitive intervention effects. The size of squares representing the point estimates is proportional to the weight assigned to the subgroup.