Low Birth Weight InfantsNCT06559020
Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan
A study testing Kangroo mother care in people with Low Birth Weight Infants and Preterm Infants, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight Infants, Preterm Infants
- What is being tested?
- Kangroo mother care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women who were able to follow the program instructions,
- permanent residents of Lahore and its periphery and willing to be part of program for the one-year time period,
- live newborn babies delivered either vaginally or through caesarean section with birth weight of 1.5 to 2 kg,
- gestational age between 28 to 36 weeks.
Who cannot join
- an infant or mother diagnosed with a life-threatening ailment, major disease, or major malformations,
- early-detected major conditions arising from perinatal problems, such as severe hypoxic-ischemic encephalopathy, pulmonary hypertension,
- incidence of severe infection measured as nosocomial infections requiring systemic antibiotics or infections, severe respiratory distress, and hypothermia episodes (temperature less than 35C).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical sciences
Lahore, Punjab Province, 54000
About this study
Official title: Predictors for Opting for Kangaroo Mother Care in Pakistan and Infant Development Outcomes Based on a Quasi-Experimental Intervention
This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.
Read the detailed description
This quasi-experimental study was conducted in the Obstetrics and Gynecology Department of Services Institute of Medical Sciences (SIMS), Lahore, Pakistan, to compare the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on low birth weight infants. A total of 400 infants (200 in each group) born between January 2020 and December 2022 were included in the study, with participants selected based on specific inclusion criteria and informed consent obtained. KMC involved continuous skin-to-skin contact between mother and infant during the hospital stay and continued at home for at least 8 hours daily. The follow-up schedule included appointments at six weeks after birth, monthly visits until six months of age, and quarterly visits until the infants reached one year of age. During these visits, the study collected data on infant growth, developmental milestones, breastfeeding practices, and vaccination status. The study was ethically approved by the research ethics committee, and data collection was conducted during scheduled follow-up visits to the outpatient department.
- Conditions
- Low Birth Weight Infants, Preterm Infants
- Being tested
- Kangroo mother care
- Keywords
- Kangroo mother care, Infant development, Breast feeding, Neonatal death, Vaccination, Pakistan
- Medical subject headings
- Breast Feeding, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangroo mother careBehavioural
Kangaroo Mother Care (KMC) involves continuous skin-to-skin contact between the mother (or another family member) and the infant, aimed at promoting thermal regulation, breastfeeding, and bonding. In this study, KMC was initiated in the hospital and continued at home for a minimum of 8 hours daily.
| Study group | Role | What they receive |
|---|---|---|
| kangroo mother care | Experimental | he KMC group will receive continuous skin-to-skin contact between mother and infant for 24 hours a day, with support and training in kangaroo positioning and exclusive breastfeeding. Receives: Behavioral: Kangroo mother care |
| conventional care | No intervention | The control group will receive conventional neonatal care, which includes placing newborns in open cots with appropriate heating or cooling based on weather conditions. Mothers will receive guidance on the benefits of exclusive breastfeeding and support to initiate breastfeeding, but will not have the structured kangaroo mother care provided to the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Breastfeeding
breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year
Measured: from 2 hours to 1 year
Number of babies with complete vaccination
infant receiving all scheduled vaccinations within their first year of life
Measured: 1 year
Average weight of baby
Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year
Measured: 1 year
average length of infant
Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year
Measured: 1 year
Average head circumference of infant
Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year
Measured: 1 year
Number of babies Holding head up
baby able to hold their head up
Measured: 3 months
Number of babies Sitting without support
Baby gets into sitting position without help
Measured: 6 months
Number of babies roll over
baby able to roll from side to side
Measured: 8 months
Number of babies crawling
baby able to move forward on hands and knees
Measured: 10 months
Number of babies babbles
baby able to produce repititive incomprehensible sounds
Measured: 6 months
Number of babies produce 2 syllable sounds
baby able to produce words that have two definite sounds
Measured: 9 months
cumulative Mortality rate
Death of baby
Measured: 1 year
Secondary outcomes (2)
Number of babies with Hypothermia
core body temperature less than 35 degree celsius
Measured: 72 hours
Number of babies with Sepsis
infection leading to life threatening inflammatory response
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a quasi-experimental design with parallel assignment. Participants were self-selected into two groups: one receiving Kangaroo Mother Care (KMC) and the other receiving Conventional Care (CC). The intervention was applied without randomization, and both groups were followed for one year to assess differences in growth, developmental milestones, breastfeeding practices, vaccination status, and mortality among low birth weight and preterm infants.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
- Investigators
- Tayyiba Wasim, FCPS, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559020
- Sponsor's protocol ID
- IRB/2023/1099/SIMS
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Opting for Kangaroo Mother Care in Pakistan and Infant Development Outcomes Based on a Quasi-Experimental Intervention
- ClinicalTrials.gov ID
- NCT06559020
- Acronym / sponsor ID
- IRB/2023/1099/SIMS
- Conditions
- Low Birth Weight Infants, Preterm Infants
- Keywords
- Kangroo mother care, Infant development, Breast feeding, Neonatal death, Vaccination, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.
Detailed description
This quasi-experimental study was conducted in the Obstetrics and Gynecology Department of Services Institute of Medical Sciences (SIMS), Lahore, Pakistan, to compare the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on low birth weight infants. A total of 400 infants (200 in each group) born between January 2020 and December 2022 were included in the study, with participants selected based on specific inclusion criteria and informed consent obtained. KMC involved continuous skin-to-skin contact between mother and infant during the hospital stay and continued at home for at least 8 hours daily. The follow-up schedule included appointments at six weeks after birth, monthly visits until six months of age, and quarterly visits until the infants reached one year of age. During these visits, the study collected data on infant growth, developmental milestones, breastfeeding practices, and vaccination status. The study was ethically approved by the research ethics committee, and data collection was conducted during scheduled follow-up visits to the outpatient department.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a quasi-experimental design with parallel assignment. Participants were self-selected into two groups: one receiving Kangaroo Mother Care (KMC) and the other receiving Conventional Care (CC). The intervention was applied without randomization, and both groups were followed for one year to assess differences in growth, developmental milestones, breastfeeding practices, vaccination status, and mortality among low birth weight and preterm infants.
| Arm | Type | Receives |
|---|---|---|
| kangroo mother care | Experimental | Behavioral: Kangroo mother carehe KMC group will receive continuous skin-to-skin contact between mother and infant for 24 hours a day, with support and training in kangaroo positioning and exclusive breastfeeding. |
| conventional care | No intervention | –The control group will receive conventional neonatal care, which includes placing newborns in open cots with appropriate heating or cooling based on weather conditions. Mothers will receive guidance on the benefits of exclusive breastfeeding and support to initiate breastfeeding, but will not have the structured kangaroo mother care provided to the experimental group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- women who were able to follow the program instructions,
- permanent residents of Lahore and its periphery and willing to be part of program for the one-year time period,
- live newborn babies delivered either vaginally or through caesarean section with birth weight of 1.5 to 2 kg,
- gestational age between 28 to 36 weeks.
Key exclusion criteria (3 listed)
- an infant or mother diagnosed with a life-threatening ailment, major disease, or major malformations,
- early-detected major conditions arising from perinatal problems, such as severe hypoxic-ischemic encephalopathy, pulmonary hypertension,
- incidence of severe infection measured as nosocomial infections requiring systemic antibiotics or infections, severe respiratory distress, and hypothermia episodes (temperature less than 35C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangroo mother careKangaroo Mother Care (KMC) involves continuous skin-to-skin contact between the mother (or another family member) and the infant, aimed at promoting thermal regulation, breastfeeding, and bonding. In this study, KMC was initiated in the hospital and continued at home for a minimum of 8 hours daily. | Behavioural | kangroo mother care |
Primary outcome
Duration of Breastfeeding
Time frame: from 2 hours to 1 year
breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year
Number of babies with complete vaccination
Time frame: 1 year
infant receiving all scheduled vaccinations within their first year of life
Average weight of baby
Time frame: 1 year
Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year
average length of infant
Time frame: 1 year
Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year
Average head circumference of infant
Time frame: 1 year
Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year
Number of babies Holding head up
Time frame: 3 months
baby able to hold their head up
Number of babies Sitting without support
Time frame: 6 months
Baby gets into sitting position without help
Number of babies roll over
Time frame: 8 months
baby able to roll from side to side
Number of babies crawling
Time frame: 10 months
baby able to move forward on hands and knees
Number of babies babbles
Time frame: 6 months
baby able to produce repititive incomprehensible sounds
Number of babies produce 2 syllable sounds
Time frame: 9 months
baby able to produce words that have two definite sounds
cumulative Mortality rate
Time frame: 1 year
Death of baby
2 secondary outcomes
Number of babies with Hypothermia
Time frame: 72 hours
Number of babies with Sepsis
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayyiba Wasim, FCPS principal investigator
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangroo mother care in people with Low Birth Weight Infants and Preterm Infants, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Breastfeeding (time frame: from 2 hours to 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.