Weight GainNCT05640297
"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
A study testing KMC with Massage therapy in people with Weight Gain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge. Read more about this study
- Who is it for?
- Ages 1 hour to 28 monthsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- KMC with Massage therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Mar 2022to 1 Oct 2023
- 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 1 hour to 28 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Gestational age <34 weeks. or 2. Neonates weighing less than 2000 gm. With any one of the following
- Hemodynamically stable.
- Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.
- Gestational age <34 weeks. or
- Neonates weighing less than 2000 gm. With any one of the following
- Hemodynamically stable.
- Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.
Who cannot join
- Hemodynamically unstable critically ill neonates.
- Newborn with severe perinatal asphyxia and seizure
- Newborn requiring exchange transfusion.
- Newborn with major congenital and chromosomal abnormalities.
- Newborn with sepsis, IVH, shock, necrotizing enterocolitis.
- Newborn with major surgical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.
Read the detailed description
Primary phase of the transition from the fetal to post-natal period is the most important, vulnerable and stressful phase in human life. Hence, care methods that facilitate better adaptation of neonates with early post¬natal environment have an important role in growth of newborns. Attachment is a unique relationship between the parents and their infants that begins during pregnancy when fetus grows in uterus and continues to the postnatal period with the relationship of mother and baby. This reciprocal parent-infant relationship is an essential element of the attachment process that helps relaxation of both mother and the infant. Kangaroo mother care has facilitated infant growth and decreased morbidities and hospital stay. Adding massage therapy may potentiate the kangaroo mother care benefits and better growth in preterm low birth weight infants admitted in neonatal intensive care unit. However, there is a very few published studies from Bangladesh regarding this. The objective of this study is to evaluate whether kangaroo mother care plus massage therapy is associated with better growth of preterm low birth weight infants.
This study will be conducted in the department of Neonatology in Bangabandhu Sheikh Mujib Medical University over a period of eighteen months. After detailed history taking and thorough general and systemic examination the newborn will enter in to intervention or control group after taking informed written consent. Randomization will be done by random allocation software (version 2.0 developed by Mahmood Saghaei, Iran). Patient will be enrolled according to the inclusion and exclusion criteria. Thereafter control group will receive standard kangaroo mother care and intervention group will get massage therapy along with kangaroo mother care, up to discharge both group will be meticulously monitored by the investigator. Data will be collected by structured questionnaire and analysis will be done by The Statistical Package for Social Sciences (SPSS), version 25.
- Conditions
- Weight Gain
- Being tested
- KMC with Massage therapy
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KMC with Massage therapyBehavioural
investigator will provide tactile and kinesthetic massage
| Study group | Role | What they receive |
|---|---|---|
| KMC with Massage therapy | Experimental | Preterm low birth weight babies who will get KMC will also receive massage therapy Receives: Behavioral: KMC with Massage therapy |
| KMC only | No intervention | Preterm low birth weight babies who will get KMC only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in grams
Pattern of weight gain in grams using KINLEE EBST-20 weighing scale.
Measured: 18 months
Secondary outcomes (1)
OFC in centimeter
pattern of head growth using measuring tape
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start30 Mar 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh College Of Physicians And Surgeons (BCPS)
- Responsible party
- Principal investigator, Dr. Sonia Aktar, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- sonia aktar, MBBS,DCH, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640297
- Sponsor's protocol ID
- 3838
- Status last verified
- Mar 2023
- First submitted
- 15 Nov 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion principle investigator will share
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
- ClinicalTrials.gov ID
- NCT05640297
- Acronym / sponsor ID
- 3838
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Collaborators
- Bangladesh College Of Physicians And Surgeons (BCPS)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.
Detailed description
Primary phase of the transition from the fetal to post-natal period is the most important, vulnerable and stressful phase in human life. Hence, care methods that facilitate better adaptation of neonates with early post¬natal environment have an important role in growth of newborns. Attachment is a unique relationship between the parents and their infants that begins during pregnancy when fetus grows in uterus and continues to the postnatal period with the relationship of mother and baby. This reciprocal parent-infant relationship is an essential element of the attachment process that helps relaxation of both mother and the infant. Kangaroo mother care has facilitated infant growth and decreased morbidities and hospital stay. Adding massage therapy may potentiate the kangaroo mother care benefits and better growth in preterm low birth weight infants admitted in neonatal intensive care unit. However, there is a very few published studies from Bangladesh regarding this. The objective of this study is to evaluate whether kangaroo mother care plus massage therapy is associated with better growth of preterm low birth weight infants.
This study will be conducted in the department of Neonatology in Bangabandhu Sheikh Mujib Medical University over a period of eighteen months. After detailed history taking and thorough general and systemic examination the newborn will enter in to intervention or control group after taking informed written consent. Randomization will be done by random allocation software (version 2.0 developed by Mahmood Saghaei, Iran). Patient will be enrolled according to the inclusion and exclusion criteria. Thereafter control group will receive standard kangaroo mother care and intervention group will get massage therapy along with kangaroo mother care, up to discharge both group will be meticulously monitored by the investigator. Data will be collected by structured questionnaire and analysis will be done by The Statistical Package for Social Sciences (SPSS), version 25.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| KMC with Massage therapy | Experimental | Behavioral: KMC with Massage therapyPreterm low birth weight babies who will get KMC will also receive massage therapy |
| KMC only | No intervention | –Preterm low birth weight babies who will get KMC only |
Who may qualify
- Ages
- 1 hour to 28 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 1. Gestational age <34 weeks. or 2. Neonates weighing less than 2000 gm. With any one of the following
Key exclusion criteria (6 listed)
- Hemodynamically unstable critically ill neonates.
- Newborn with severe perinatal asphyxia and seizure
- Newborn requiring exchange transfusion.
- Newborn with major congenital and chromosomal abnormalities.
- Newborn with sepsis, IVH, shock, necrotizing enterocolitis.
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 |
|---|---|---|
| KMC with Massage therapyinvestigator will provide tactile and kinesthetic massage | Behavioural | KMC with Massage therapy |
Primary outcome
Weight in grams
Time frame: 18 months
Pattern of weight gain in grams using KINLEE EBST-20 weighing scale.
1 secondary outcome
OFC in centimeter
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. After completion principle investigator will share
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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.
sonia aktar, MBBS,DCH principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KMC with Massage therapy in people with Weight Gain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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 Bangladesh. 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?
Results are not available in the source record.
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?
Weight in grams (time frame: 18 months). 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 29 Mar 2023.