Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403567799525 Date of Approval: 15/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Addressing neonatal mortalities through prolonged Immediate Kangaroo Mother Care in Kibaha Tanzania
Official scientific title Addressing neonatal mortalities through prolonged Immediate Kangaroo Mother Care at Tumbi Regional Refferral Hospital in Kibaha Tanzania
Brief summary describing the background and objectives of the trial Neonatal mortality is a global public health issue, and efforts to reduce child mortality are one of the goals of the United Nations' 2030 agenda for Sustainable Development. When a new born dies within the first seven days of life, this is referred to as early neonatal mortality. In early neonates, factors such as meconium staining, hypothermia, prematurity, low birth weight, infections, asphyxia and birth trauma all increase the risk of death. Despite interventions, neonatal mortality in Tanzania has remained a public health issue over time (34.1 per 1000 live births). Interventions such as helping babies breathe and performing basic resuscitation, cord care, kangaroo mother care, and exclusive breastfeeding are all important interventions to reduce neonatal mortality. Since Kangaroo Mother Care (KMC) is a cost-effective intervention and has proven to reduce preterm and low birth weight neonatal mortality, hence the study aims at reduce deaths of neonates in the first week of life through prolonged Immediate Kangaroo Mother Care (I-KMC) taken with exclusive breast feeding. Main objective To assess the effectiveness of prolonged immediate Kangaroo Mother Care (iKMC) combined with exclusive breastfeeding in reducing deaths in the first week of life among preterm neonates Specific Objectives 1. To assess the effect of immediate Kangaroo Mother Care in reducing neonatal mortality within the first week of life among preterm babies 2. To assess the effect of immediate Kangaroo Mother Care combined with exclusive breastfeeding in reducing the risk of infections among babies born early and/or small
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IKMC
Disease(s) or condition(s) being studied Prematurity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/03/2024
Actual trial start date 15/03/2024
Anticipated date of last follow up 15/03/2025
Actual Last follow-up date 15/06/2025
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 176
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group KMC started after baby stabilization in the incubator NA 12 hours per day for 7 days Mothers with their preterm and/or LBW neonates in the control group will assume KMC when the baby is stable from the incubator, when the mother is stable to take KMC position. Neonates will stay in Kangaroo position for12 hours per day for 7 days; Mother will be not be required to have a substitute.. Study nurses will support mothers and monitor exclusive breast feeding. Further, during the study period, a study nurse will monitor babies’ temperature, respiratory rate, weight and determine any possible danger signs for reaction in seven days post delivery 88 Uncontrolled
Experimental Group Immediate Kangaroo Mother Care N/A 20 hours per day for 7 days Mothers with their preterm and/or LBW neonates in the intervention arm will assume KMC the soonest possible time after delivery (in five hours), neonates will stay in Kangaroo position for ≥20 hours per day for 7 days; mother will be required to have a substitute who will assist a mother to take KMC. Study nurses will support mothers and monitor exclusive breast feeding. Further, during the study period, a study nurse will monitor babies’ temperature, respiratory rate, weight and determine any possible danger signs for reaction in seven days post delivery 88
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Preterm live births between 28-36 weeks of gestation, Babies with birth weight between 1000g to <2500g. Healthy mothers with a substitute both willing to consent for participation and Mothers giving birth to a maximum of twin babies Neonates with signs of severe congenital malfunctions and/or difficulties in breathing which will require any medical attention that cannot be carried out while the baby is in KMC position, Mothers who will present with sickness and not be able to provide breast milk, Mothers who will not present with a substitute for the I-KMC and Death of either a baby or a mother Mothers under 18 years of age Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2023 National Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduced number of deaths in the intervention arm as compared to the control. Recruitment in this study will take 12 months, the time points at which an outcome will be recorded will be the seventh day of life. All recruited neonates will stay in the study for seven days.
Secondary Outcome Reduced risk of infections among preterm babies in the intervention arm The occurrence of infection will be measured in the seven days of life of a preterm baby.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tumbi Regional Referral Hospital Tumbi Regional Referral Hospital Pwani United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Laerdal Foundation Stavanger Sentrum Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute for Medical Research Muhimbili center Chippe building, MUHAS main campus Dar es Salaam 11102 United Republic of Tanzania Public Research institution
COLLABORATORS
Name Street address City Postal code Country
Muhimbili National Hospital Maliki Road, Upanga Dar es Salaam 11102 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edna Majaliwa ednasiima07@gmail.com +255717036246 Maliki road, Upanga
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Pediatric endocrinologist
Role Name Email Phone Street address
Scientific Enquiries Johnson Mshiu johnson.mshiu@nimr.or.tz +255657551250 Muhimbili, Upanga
City Postal code Country Position/Affiliation
Dar es Salaam 11102 United Republic of Tanzania NIMR Muhimbili center
Role Name Email Phone Street address
Public Enquiries Felix Christopher felixie1986@gmail.com +255652199922 Muhimbili, Upanga
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania NIMR Muhimbili center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Participant Identification: I. Each participant will be assigned a unique identification code to maintain confidentiality, only this identification will be available for sharing. Personal identifiers such as name, address, and contact information will not be available for sharing 2. Demographic Information: I. Age of the mother II. Gestational age of the infant at birth III. Birth weight of the infant 3. Intervention Details: I. Group assignment (prolonged KMC or standard KMC) II. Duration and frequency of KMC sessions III. Adherence to the KMC protocol IV. Any deviations from the assigned intervention 4. Clinical Data: I. Vital signs of the infant (e.g., heart rate, respiratory rate, temperature) II. Neonatal complications (e.g., sepsis, respiratory distress syndrome) III. Duration of hospital stay IV. Neonatal mortality status (alive or deceased) V. Breastfeeding practices (e.g., initiation, exclusivity) 6. Follow-up Data: I. Any post-discharge follow-up visits II. Outcomes measured during follow-up (e.g., growth parameters, developmental milestones) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Six months after study end date Anyone is allowed to request access to findings of this trial, data requests will be addressed to the Principle investigator. If the data is required outside Tanzania, the data transfer agreement will be signed as instructed by the National Research ethics Committee of the National Institute for Medical Research Tanzania
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information