Evidence map›Paper›PMID 37038239›Full record

ArticleTrials2023

Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study.

E A Adejuyigbe, I Agyeman, P Anand, H C Anyabolu, S Arya, E N Assenga, S Badhal, N W Brobby, H K Chellani, N Chopra and 26 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
6.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 11 institutions in 7 countries.

E A AdejuyigbeDepartment of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria.
I AgyemanKomfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana.
P AnandDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
H C AnyaboluDepartment of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria.
S AryaDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
E N AssengaDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania.
S BadhalVardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
N W BrobbyDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
H K ChellaniDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India. chellaniharish@gmail.com.
N ChopraDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
P K DebataDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
Q DubeQueen Elizabeth Central Hospital, Blantyre, Malawi.
T DuaDepartment of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.
L GadamaDepartment of Obstetrics and Gynaecology, Kamuzu University of Health Sciences, Blantyre, Malawi.
R GeraDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
C K HammondDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
S JainVardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
F KantumbizaDepartment of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi.
K KawazaDepartment of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi.
E N KijaDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania.
P LalAtal Bihari Vajpayee Institute of Medical Sciences &, Dr Ram Manohar Lohia Hospital, New Delhi, 110001, India.
M MallewaDepartment of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi.
M K ManuKomfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana.
A MehtaVardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
T MhangoDepartment of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi.
H E NaburiDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania.
S NewtonSchool of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
I NyanorResearch and Development, Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana.
P A NyakoDepartment of Psychiatry, Child And Adolescent Mental Health, Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana.
O J OkeDepartment of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria.
A PatelDepartment of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.
G Phlange-RhuleClinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster, PO Box #04, Faridabad, 121001, India.
R SehgalDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India.
R SinghalTranslational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster, PO Box #04, 121001, Faridabad, India.
N WadhwaFaridabad-Gurgaon Expressway, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, 3Rd MilestonePost Box #04, Faridabad, Haryana, 121001, India. nitya.wadhwa@thsti.res.in.ORCID http://orcid.org/0000-0002-9435-1842
A B YiadomDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
Vardhman Mahavir Medical College & Safdarjung Hospital · INKomfo Anokye Teaching Hospital · GHKamuzu Central Hospital · MWMuhimbili University of Health and Allied Sciences · TZObafemi Awolowo University · NGTranslational Health Science and Technology Institute · INAtal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital · INBoston Children's Hospital · USKwame Nkrumah University of Science and Technology · GHQueen Elizabeth Central Hospital · MWWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundPreterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment.

methodsThis prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. DISCUSSION: Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors.

trial registrationClinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369.

Indexed as

Kangaroo-Mother Care MethodPremature BirthBirth WeightFemaleFollow-Up StudiesHumansInfant MortalityInfant, NewbornProspective StudiesRandomized Controlled Trials as TopicWeight GainImmediate Kangaroo Mother Care (iKMC)Low- and middle-income countriesLow-birth-weight babiesNeurodevelopment

Identifiers

PMID37038239
PMCPMC10088121
OpenAlexW4363674122

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.