Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial

Sunita Taneja, Bireshwar Sinha, Ravi Prakash Upadhyay, Sarmila Mazumder, Halvor Sommerfelt, Jose Martines, Suresh Kumar Dalpath, Rakesh Gupta, Patricia Kariger, Rajiv Bahl, Nita Bhandari, Tarun Dua, ciKMC development study group, Farah Abbasi, Vaishali Panwar, Sugandhi Nagpal, Medha Shekhar, Runa Ghosh, Jasmine Kaur, Brinda Dube, Sunita Taneja, Bireshwar Sinha, Ravi Prakash Upadhyay, Sarmila Mazumder, Halvor Sommerfelt, Jose Martines, Suresh Kumar Dalpath, Rakesh Gupta, Patricia Kariger, Rajiv Bahl, Nita Bhandari, Tarun Dua, ciKMC development study group, Farah Abbasi, Vaishali Panwar, Sugandhi Nagpal, Medha Shekhar, Runa Ghosh, Jasmine Kaur, Brinda Dube

Abstract

Background: In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy.

Method: This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment.

Results: In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent.

Conclusion: Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights.

Trial registration: The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.

Keywords: Child development; Kangaroo mother care; Low birth weight, community initiated.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial profile
Fig. 2
Fig. 2
Plot showing equivalence of the (a) composite cognitive scores (b) language scores and (c) motor scores at 12 months of age among the two study groups

References

    1. Katz J, Lee AC, Kozuki N, Lawn JE, Cousens S, Blencowe H, Ezzati M, Bhutta ZA, Marchant T, Willey BA et al: Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis. Lancet 2013, 382(9890):417-425. doi: 10.1016/S0140-6736(13)60993-9. Epub 62013 Jun 60996.
    1. Christian P, Lee SE, Donahue Angel M, Adair LS, Arifeen SE, Ashorn P, Barros FC, Fall CH, Fawzi WW, Hao W et al: Risk of childhood undernutrition related to small-for-gestational age and preterm birth in low- and middle-income countries. Int J Epidemiol 2013, 42(5):1340-1355. doi: 10.1093/ije/dyt109. Epub 2013 Aug 1346.
    1. Allotey J, Zamora J, Cheong-See F, Kalidindi M, Arroyo-Manzano D, Asztalos E, van der Post J, Mol BW, Moore D, Birtles D, et al. Cognitive, motor, behavioural and academic performances of children born preterm: a meta-analysis and systematic review involving 64 061 children. Bjog. 2018;125(1):16–25. doi: 10.1111/1471-0528.14832.Epub12017Oct14811.
    1. Whitaker AH, Feldman JF, Lorenz JM, Shen S, McNicholas F, Nieto M, McCulloch D, Pinto-Martin JA, Paneth N. Motor and cognitive outcomes in nondisabled low-birth-weight adolescents: early determinants. Arch Pediatr Adolesc Med. 2006;160(10):1040–1046. doi: 10.1001/archpedi.1160.1010.1040.
    1. Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016;(8):CD002771. 10.1002/14651858.CD002771.pub4.
    1. WHO . Kangaroo mother care: a practical guide. Geneva: World Health Organization; 2003.
    1. Bear RJ, Mellor DJ. Continuing education module-kangaroo mother care 2: potential beneficial impacts on brain development in premature infants. J Perinat Educ. 2017;26(4):177–184. doi: 10.1891/1058-1243.26.4.177.
    1. Bera A, Ghosh J, Singh AK, Hazra A, Mukherjee S, Mukherjee R. Effect of kangaroo mother care on growth and development of low birthweight babies up to 12 months of age: a controlled clinical trial. Acta Paediatr. 2014;103(6):643–650. doi: 10.1111/apa.12618.
    1. Charpak N, Ruiz-Pelaez JG, Figueroa de CZ, Charpak Y. A randomized, controlled trial of kangaroo mother care: results of follow-up at 1 year of corrected age. Pediatrics. 2001;108(5):1072–1079. doi: 10.1542/peds.108.5.1072.
    1. Ohgi S, Fukuda M, Moriuchi H, Kusumoto T, Akiyama T, Nugent JK, Brazelton TB, Arisawa K, Takahashi T, Saitoh H. Comparison of kangaroo care and standard care: behavioral organization, development, and temperament in healthy, low-birth-weight infants through 1 year. J Perinatol. 2002;22(5):374–379. doi: 10.1038/sj.jp.7210749.
    1. Feldman R, Eidelman AI. Skin-to-skin contact (kangaroo care) accelerates autonomic and neurobehavioural maturation in preterm infants. Dev Med Child Neurol. 2003;45(4):274–281. doi: 10.1111/j.1469-8749.2003.tb00343.x.
    1. Charpak N, Tessier R, Ruiz JG, Hernandez JT, Uriza F, Villegas J, Nadeau L, Mercier C, Maheu F, Marin J, et al. Twenty-year Follow-up of Kangaroo Mother Care Versus Traditional Care. Pediatrics. 2017;139(1). 10.1542/peds.2016-2063 Epub 2016 Dec 2012.
    1. Ropars S, Tessier R, Charpak N, Uriza LF. The long-term effects of the kangaroo mother care intervention on cognitive functioning: results from a longitudinal study. Dev Neuropsychol. 2018;43(1):82–91. doi: 10.1080/87565641.87562017.81422507.
    1. Schneider C, Charpak N, Ruiz-Pelaez JG, Tessier R. Cerebral motor function in very premature-at-birth adolescents: a brain stimulation exploration of kangaroo mother care effects. Acta Paediatr. 2012;101(10):1045–1053. doi: 10.1111/j.1651-2227.2012.02770.x.
    1. Scher MS, Ludington-Hoe S, Kaffashi F, Johnson MW, Holditch-Davis D, Loparo KA. Neurophysiologic assessment of brain maturation after an 8-week trial of skin-to-skin contact on preterm infants. Clin Neurophysiol. 2009;120(10):1812–1818. doi: 10.1016/j.clinph.2009.08.004.
    1. Feldman R, Rosenthal Z, Eidelman AI. Maternal-preterm skin-to-skin contact enhances child physiologic organization and cognitive control across the first 10 years of life. Biol Psychiatry. 2014;75(1):56–64. doi: 10.1016/j.biopsych.2013.08.012.
    1. GOI . Kangaroo mother care and optimal feeding of low birth weight: Operational guidelines. India: Child Health Division, Ministry of Health and Family Welfare, Government of India; 2014.
    1. Neogi SB, Chauhan M, Sharma J, Negandhi P, Sethy G. Rolling out of kangaroo mother care in secondary level facilities in Bihar-Some experiences. Indian J Public Health. 2016;60(4):302–308. doi: 10.4103/0019-4557X.195864.
    1. Bergh AM, de Graft-Johnson J, Khadka N, Om'Iniabohs A, Udani R, Pratomo H, De Leon-Mendoza S. The three waves in implementation of facility-based kangaroo mother care: a multi-country case study from Asia. BMC Int Health Hum Rights. 2016;16:4. doi: 10.1186/s12914-12016-10080-12914.
    1. Sloan NL, Ahmed S, Mitra SN, Choudhury N, Chowdhury M, Rob U, Winikoff B. Community-based kangaroo mother care to prevent neonatal and infant mortality: a randomized, controlled cluster trial. Pediatrics. 2008;121(5):e1047–e1059. doi: 10.1542/peds.2007-0076.
    1. Mazumder S, Taneja S, Dube B, Bhatia K, Ghosh R, Shekhar M, Sinha B, Bahl R, Martines J, Bhan MK, et al. Effect of community-initiated kangaroo mother care on survival of infants with low birthweight: a randomised controlled trial. Lancet (London, England). 2019.
    1. Mazumder S, Upadhyay RP, Hill Z, Taneja S, Dube B, Kaur J, Shekhar M, Ghosh R, Bisht S, Martines JC, et al. Kangaroo mother care: using formative research to design an acceptable community intervention. BMC Public Health. 2018;18(1):307. doi: 10.1186/s12889-018-5197-z.
    1. Mazumder S, Taneja S, Dalpath SK, Gupta R, Dube B, Sinha B, Bhatia K, Yoshida S, Norheim OF. Bahl R, et al. Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial. Trials. 2017;18(1):262. doi: 10.1186/s13063-13017-11991-13067.
    1. MOHFW . Home based newborn care operational guidelines. India: Ministry of Health and Family Welfare, Government of India; 2014.
    1. Bayley N. Bayley Scales of Infant and Toddler Development: Administration Manual, 3rd edition. United States of America: Psychorp; 2006.
    1. Murray-Kolb LE, Rasmussen ZA, Scharf RJ, Rasheed MA, Svensen E, Seidman JC, Tofail F, Koshy B, Shrestha R, Maphula A, et al. The MAL-ED cohort study: methods and lessons learned when assessing early child development and caregiving mediators in infants and young children in 8 low- and middle-income countries. Clin Infect Dis. 2014;59(Suppl 4):S261–S272. doi: 10.1093/cid/ciu1437.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Teti DM, Gelfand DM. Behavioral competence among mothers of infants in the first year: the mediational role of maternal self-efficacy. Child Dev. 1991;62(5):918–929. doi: 10.2307/1131143.
    1. Condon J, Corkindale C. The assessment of parent-to-infant attachment: development of a self-report questionnaire instrument. J Reprod Infant Psychol. 1998;16(1):57–76. doi: 10.1080/02646839808404558.
    1. Casey PH, Barrett K, Bradley RH, Spiker D. Pediatric clinical assessment of mother-child interaction: concurrent and predictive validity. J Dev Behav Pediatr. 1993;14(5):313–317. doi: 10.1097/00004703-199310000-00004.
    1. Ment LR, Hirtz D, Huppi PS. Imaging biomarkers of outcome in the developing preterm brain. Lancet Neurol. 2009;8(11):1042–1055. doi: 10.1016/S1474-4422(09)70257-1.
    1. Boardman JP, Counsell SJ, Rueckert D, Hajnal JV, Bhatia KK, Srinivasan L, Kapellou O, Aljabar P, Dyet LE, Rutherford MA, et al. Early growth in brain volume is preserved in the majority of preterm infants. Ann Neurol. 2007;62(2):185–192. doi: 10.1002/ana.21171.
    1. Upadhyay RP, Naik G, Choudhary TS, Chowdhury R, Taneja S, Bhandari N, Martines JC, Bahl R, Bhan MK. Cognitive and motor outcomes in children born low birth weight: a systematic review and meta-analysis of studies from South Asia. BMC Pediatr. 2019;19(1):35. doi: 10.1186/s12887-019-1408-8.
    1. Colombo J, Carlson SE, Cheatham CL, Fitzgerald-Gustafson KM, Kepler A, Doty T. Long-chain polyunsaturated fatty acid supplementation in infancy reduces heart rate and positively affects distribution of attention. Pediatr Res. 2011;70(4):406–410. doi: 10.1203/PDR.0b013e31822a59f5.
    1. Colombo J, Carlson SE, Cheatham CL, Shaddy DJ, Kerling EH, Thodosoff JM, Gustafson KM, Brez C. Long-term effects of LCPUFA supplementation on childhood cognitive outcomes. Am J Clin Nutr. 2013;98(2):403–412. doi: 10.3945/ajcn.112.040766.
    1. Grahn JA, Parkinson JA, Owen AM. The cognitive functions of the caudate nucleus. Prog Neurobiol. 2008;86(3):141–155. doi: 10.1016/j.pneurobio.2008.09.004.
    1. Suffren S, Angulo D, Ding Y, Reyes P, Marin J, Hernandez JT, Charpak N, Lodygensky GA. Long-term attention deficits combined with subcortical and cortical structural central nervous system alterations in young adults born small for gestational age. Early Hum Dev. 2017;110:44–49. doi: 10.1016/j.earlhumdev.2017.04.016.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다