scholarly journals Kangaroo Mother Care: A Randomized Controlled Trial on Effectiveness of Early Kangaroo Mother Care for the Low Birthweight Infants in Addis Ababa, Ethiopia

2005 ◽  
Vol 51 (2) ◽  
pp. 93-97 ◽  
Author(s):  
Bogale Worku ◽  
Assaye Kassie
Keyword(s):  
Randomized Controlled Trial ◽  
Low Birthweight ◽  
Addis Ababa ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Randomized Controlled

scholarly journals Health equity impact of community-initiated kangaroo mother care: a randomized controlled trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Tarun Shankar Choudhary ◽  
Sarmila Mazumder ◽  
Øystein Ariansen Haaland ◽  
Sunita Taneja ◽  
Rajiv Bahl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Vulnerable Groups ◽  
Randomized Controlled ◽  
Beneficial Impact ◽  
The Difference ◽  
And Control ◽  
Concentration Indices

Abstract Background Kangaroo mother care (KMC) can substantially enhance overall survival of low birthweight babies. In a large randomized controlled trial, we recently showed that supporting mothers to provide community initiated KMC (ciKMC) can reduce mortality among infants up to 180 days of life by 25% (hazard ratio (HR) 0.75). With the current analysis, we aimed to explore if ciKMC promotion leads to increased inequity in survival. Methods In the trial we randomized 8402 low birthweight babies to a ciKMC (4480 babies) and a control (3922 babies) arm, between 2015 and 2018 in Haryana, India. We estimated the difference in concentration indices, which measure inequality, between babies in the ciKMC and control arms for survival until 180 days of life. Further, we compared the effect of ciKMC promotion across subgroups defined by socioeconomic status, caste, maternal literacy, infant’s sex, and religion. Results Our intervention did not increase survival inequity, as the concentration index in the ciKMC arm of the trial was 0.05 (95% CI -0.07 to 0.17) lower than in the control arm. Survival impact was higher among those belonging to the lower two wealth quintiles, those born to illiterate mothers and those belonging to religions other than Hindu. Conclusions We found that ciKMC promotion did not increase inequity in survival associated with wealth. The beneficial impact of ciKMC tended to be larger among vulnerable groups. Supporting mothers to provide KMC at home to low birthweight babies will not increase and could indeed reduce inequities in infant survival. Trial registration ClinicalTrials.gov, NCT02653534. Registered January 12, 2016—Retrospectively registered.

scholarly journals Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings

2007 ◽  
Vol 87 (9) ◽  
pp. 976-985 ◽  
Author(s):  
A Cattaneo ◽  
R Davanzo ◽  
B Worku ◽  
A Surjono ◽  
M Echeverria ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Randomized Controlled

scholarly journals Effect of community-based kangaroo mother care package on neonatal mortality among preterm and low birthweight infants in rural Pakistan: Protocol for a cluster randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Sajid Soofi
Keyword(s):  
Randomized Controlled Trial ◽  
Neonatal Mortality ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Community Based ◽  
Randomized Controlled ◽  
Breastfeeding Practices ◽  
Care Package ◽  
Cluster Randomized

BACKGROUND Neonatal mortality, due to preterm birth and low birthweight, remains a major challenge for Pakistan. Kangaroo mother care is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. Kangaroo mother care has not been tried in community settings in Pakistan. We aim to implement and evaluate the effectiveness of community-based kangaroo mother care package to reduce neonatal morbidity and mortality among preterm/low birthweight infants. This will provide evidence for policy development and large-scale implementation of KMC across the country to reduce neonatal. OBJECTIVE The primary objective of this trial is to reduce neonatal mortality among preterm/low birthweight infants. The secondary objectives are growth measured as weight gain, reduction in incidence of possible serious bacterial infection (PSBI), increased exclusive breastfeeding and continued breastfeeding practices. METHODS We designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, low birth weight babies ≥1200-<2500 grams are included in the study. Kangaroo mother care package adopted after formative research consisting of KMC kit, information and counseling material, and community mobilization using KMC champions (volunteers) is implemented in the intervention clusters. The standard essential newborn care offered in the control clusters. Infants would be recruited and followed up by independent teams of data collectors. Data is collected on the duration of skin to skin contact, growth breastfeeding practices, the incidence of possible serious bacterial infection, neonatal mortality and impact on neurodevelopment. RESULTS The study protocol was approved by the Ethics Review Committee of Aga Khan University, Pakistan on February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed. Data analysis will be by intention to treat principle. The cox regression model will be used for the primary outcome of neonatal mortality, to calculate hazard ratios. The secondary outcomes will be assessed using linear or logistic regression. We expect the results to be published in peer-reviewed journals presentations at relevant conferences by autumn of 2022. CONCLUSIONS This intervention, if effective, has the “potential to be translated into a safe, effective, affordable, and widely utilized intervention” to prevent sepsis and subsequently improve survival in LBW neonates in Pakistan, and other low-and middle-income countries. CLINICALTRIAL Clinicaltrials.gov: NCT03545204

scholarly journals Administration of breast milk cell fractions to neonates with birthweight equal to or less than 1800 g: a randomized controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Minoo Fallahi ◽  
Seyed Masoud Shafiei ◽  
Naeeme Taslimi Taleghani ◽  
Maryam Khoshnood Shariati ◽  
Shamsollah Noripour ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Milk ◽  
Hospital Mortality ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Cell Fractions ◽  
Breast Milk Cell

Abstract Background Most premature and very low birthweight infants cannot tolerate breast milk feeding in the first few days of life and are deprived of its benefits. This study evaluates the clinical outcomes of administering breast milk cell fractions to neonates with a birthweight of ≤1800 g. Methods We conducted a randomized controlled trial on 156 infants in the neonatal intensive care unit of Mahdieh Maternity Hospital in Tehran, Iran, from May 2019 to April 2020. All neonates with a birthweight ≤1800 g were enrolled and divided into intervention and control groups using stratified block randomization. Neonates in the intervention group received the extracted breast milk cell fractions (BMCFs) of their own mother’s milk after being centrifuged in the first 6 to 12 h after birth. The control group received routine care, and breastfeeding was started as soon as tolerated in both groups. Study outcomes were necrotizing enterocolitis (NEC), death, and in-hospital complications. Results We divided participants into two groups: 75 neonates in the intervention group and 81 neonates in the control group. The mean birthweight of neonates was 1390.1 ± 314.4 g, and 19 (12.2%) neonates deceased during their in-hospital stay. The incidence of NEC was similar in both groups. After adjustment for possible confounders in the multivariable model, receiving BMCFs were independently associated with lower in-hospital mortality (5 [26.3%] vs. 70 (51.1%]; odds ratio (OR): 0.24; 95% confidence interval [CI] 0.07, 0.86). Also, in a subgroup analysis of neonates with birthweight less than 1500 g, in-hospital mortality was significantly lower in the intervention group (4 [9.5%] vs. 13 [30.2%]; OR: 0.24; 95% CI 0.07, 0.82). There were no differences in major complications such as bronchopulmonary dysplasia and retinopathy of prematurity between the two groups. No adverse effects occurred. Conclusions Our research demonstrated a significantly lower mortality rate in neonates (with a birthweight of ≤1800 g) who received breast milk cell fractions on the first day of life. Since this is a novel method with minimal intervention, we are looking forward to developing and evaluating this method in larger studies. Trial registration IIranian Registry of Clinical Trials. Registered 25 May 2019, IRCT20190228042868N1.

scholarly journals Community-Based Cluster Randomized Controlled Trial: Empowering Households to Identify and Provide Appropriate Care for Low-Birthweight Newborns in Nepal

2020 ◽  
Author(s):  
Stephen Hodgins ◽  
Binamra Rajbhandari ◽  
Deepak Joshi ◽  
Bharat Ban ◽  
Subarna Khatry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Care Seeking ◽  
Apparent Effect ◽  
Community Based ◽  
Randomized Controlled ◽  
Appropriate Care ◽  
Cluster Randomized ◽  
Skin To Skin

Abstract Background: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are higher risk and take protective measures. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9cm cut-off performed relatively well, differentiating normal from low birthweight.Methods: Community-based, cluster-randomized controlled trial. Objective: to determine whether family-administered screening, with targeted messages improves care practices known to mitigate LBWt risks. Participants: pregnant women participating in a parent trial in rural Nepal. Women were given a 6.9cm card to assess whether the baby’s foot is small; if so, to call number on the card for advice. Follow-up visits were made over 2 weeks following the birth, assessing for: reported skin-to-skin thermal care, and care-seeking outside the home; restricting to low birthweight (using 2 cutoffs: 2,500g and 2,000g). Randomization: 17 clusters intervention, 17 control. The study also documented steps along the presumed causal chain from intervention through behavioral impact.Results: 2,022 into intervention, 2,432 into control. Intervention arm: 519 with birthweight <2,500g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference on care-seeking; for those <2,500g RR 1.13 (95%CI: 0.97-1.131). More of those in the intervention arm reported skin-to-skin thermal care than among controls; for those <2,500g RR 2.50 (95%CI: 2.01-3.1). Process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those <2,000 as normal.Conclusions: Although the trial found an apparent effect on one key behavioral outcome, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying at-risk babies in such settings, and targeting them for appropriate care messaging.Trial registration : clinicaltrials.gov identifier: NCT02802332, registered 16 June 2016, https://clinicaltrials.gov/ct2/show/NCT02802332

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