PrematureKBMNCT04908332
Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home
A study testing Kangaroo Baby Massage in people with Premature and Low Birth Weight, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant… Read more about this study
- Who is it for?
- Ages 2 days to 3 months
- Conditions the study is for
- Premature, Low Birth Weight, Mother-Infant Interaction
- What is being tested?
- Kangaroo Baby Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteColombia
- Study dates
- 22 Jul 2021to 16 Dec 2021
- 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 2 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
- The mothers take care the infant at home
- Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
- Baby whose birth was institutional or extra-institutional.
- Mothers with training in the Kangaroo Mother Program
- Children controlled in the Ambulatory Kangaroo Mother Program
Who cannot join
- Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
- Children who have more than one ambulatory kangaroo control
- Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
- Babies with infections and other pathologies that require hospitalization during the study
- Presence of infectious diseases and other pathologies in the mother that require hospitalization
- Mother confirmed with positive test for covid 19 at the moment of the randomization
- Mothers with cognitive problems or mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá
The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM
Read the detailed description
Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.
Barnard's mother-child interaction theory supports the study
- Conditions
- Premature, Low Birth Weight, Mother-Infant Interaction, Gain, Weight, Depression, Post-Partum, Breastfeeding
- Being tested
- Kangaroo Baby Massage
- Keywords
- Massage, Kangaroo mother care, low birth weight infant, premature infant, Mother- infant interaction, domiciliary, Nursing, home health nursing, telenursing
- Medical subject headings
- Premature Birth, Weight Gain, Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Baby MassageBehavioural
Also called Masaje al Bebé Canguro, Nursing intervention KBM
The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo baby Massage | Experimental | The mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed. Receives: Behavioral: Kangaroo Baby Massage |
| Kangaroo position | Active comparator | The infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature. Receives: Behavioral: Kangaroo Baby Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.
Measured: Through study completion, an average of 20 days
Kangaroo position days at home
Number days that the infant needs to stay in kangaroo position at home
Measured: Through study completion, an average of 20 days
Secondary outcomes (4)
Alert states
The mother will observe and record YES OR NO the baby woke up during the intervention
Measured: Through study completion, an average of 20 days
Types of feeding
The mother will report whether or not the baby fed during the intervention and will identify the type of feeding (exclusive breast milk, formula or mixed)
Measured: Through study completion, an average of 20 days
Perceived maternal parental self-efficacy
The questionnaire contains 20 items with a Likert scale (1. Totally disagree, 2. disagree, 3. agree and 4. totally agree) the minimum value is 20 and the maximum is 80 and the higher scores means a better outcome.
Measured: Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization
Postnatal depression
. This scale contains 10 points of 0, 1, 2 and 3 are given according to the increase in the severity of the symptom. The points for questions 3, 5, 6, 7, 8, 9, 10 are scored in reverse order (3, 2, 1, 0). All points are added together to give the total score. A score of 10+ means worse outcome and shows the probability of depression
Measured: Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start22 Jul 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two interventions groups of 34 each, participated in the study. The first group received Nursing intervention Kangaroo Baby Massage KBM at home and the second group received Kangaroo position KP at home, the KBM will start when the infant arrives at home until they leave the kangaroo position. The KP will measure since the baby arrive at home until leave the kangaroo position.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nubia Castiblanco Lopez, Universidad Nacional de Colombia
- Investigators
- Lucy Vesga Gualdron, Professor, Study director, Universidad Nacional de ColombiaFred Manrique Abril, Professor, Study director, Universidad Nacional de ColombiaNubia Castiblanco Lopez, PhD student, Principal investigator, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908332
- Sponsor's protocol ID
- UNColombia KBM
- Acronym
- KBM
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan GJ, Labar AS, Wall S, Atun R. Kangaroo mother care: a systematic review of barriers and enablers. Bull World Health Organ. 2016 Feb 1;94(2):130-141J. doi: 10.2471/BLT.15.157818. Epub 2015 Dec 3.
PubMed 26908962Premji SS, Currie G, Reilly S, Dosani A, Oliver LM, Lodha AK, Young M. A qualitative study: Mothers of late preterm infants relate their experiences of community-based care. PLoS One. 2017 Mar 23;12(3):e0174419. doi: 10.1371/journal.pone.0174419. eCollection 2017.
PubMed 28334033Rangey PS, Sheth M. Comparative Effect of Massage Therapy versus Kangaroo Mother Care on Body Weight and Length of Hospital Stay in Low Birth Weight Preterm Infants. Int J Pediatr. 2014;2014:434060. doi: 10.1155/2014/434060. Epub 2014 May 25.
PubMed 24976830Holditch-Davis D, White-Traut R, Levy J, Williams KL, Ryan D, Vonderheid S. Maternal satisfaction with administering infant interventions in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2013 Nov-Dec;42(6):641-54. doi: 10.1111/1552-6909.12255.
PubMed 25803213Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
PubMed 31059673Vargas-Porras C, Roa-Diaz ZM, Barnes C, Adamson-Macedo EN, Ferre-Grau C, De Molina-Fernandez MI. Psychometric Properties of the Spanish Version of the Perceived Maternal Parenting Self-efficacy (PMP S-E) Tool for Primiparous Women. Matern Child Health J. 2020 May;24(5):537-545. doi: 10.1007/s10995-019-02860-y.
PubMed 31916144Stuebe A. Should Infants Be Separated from Mothers with COVID-19? First, Do No Harm. Breastfeed Med. 2020 May;15(5):351-352. doi: 10.1089/bfm.2020.29153.ams. Epub 2020 Apr 9. No abstract available.
PubMed 32271625
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá
- ClinicalTrials.gov ID
- NCT04908332
- Acronym / sponsor ID
- KBM / UNColombia KBM
- Conditions
- Premature, Low Birth Weight, Mother-Infant Interaction, Gain, Weight, Depression, Post-Partum, Breastfeeding
- Keywords
- Massage, Kangaroo mother care, low birth weight infant, premature infant, Mother- infant interaction, domiciliary, Nursing, home health nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 1 Jun 2021 (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.
The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM
Detailed description
Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.
Barnard's mother-child interaction theory supports the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two interventions groups of 34 each, participated in the study. The first group received Nursing intervention Kangaroo Baby Massage KBM at home and the second group received Kangaroo position KP at home, the KBM will start when the infant arrives at home until they leave the kangaroo position. The KP will measure since the baby arrive at home until leave the kangaroo position.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo baby Massage | Experimental | Behavioral: Kangaroo Baby MassageThe mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed. |
| Kangaroo position | Active comparator | Behavioral: Kangaroo Baby MassageThe infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature. |
Who may qualify
- Ages
- 2 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
- The mothers take care the infant at home
- Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
- Baby whose birth was institutional or extra-institutional.
- Mothers with training in the Kangaroo Mother Program
Key exclusion criteria (7 listed)
- Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
- Children who have more than one ambulatory kangaroo control
- Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
- Babies with infections and other pathologies that require hospitalization during the study
- Presence of infectious diseases and other pathologies in the mother that require hospitalization
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 |
|---|---|---|
| Kangaroo Baby MassageAlso: Masaje al Bebé Canguro, Nursing intervention KBMThe Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video | Behavioural | Kangaroo baby Massage, Kangaroo position |
Primary outcome
weight
Time frame: Through study completion, an average of 20 days
Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.
Kangaroo position days at home
Time frame: Through study completion, an average of 20 days
Number days that the infant needs to stay in kangaroo position at home
4 secondary outcomes
Alert states
Time frame: Through study completion, an average of 20 days
Types of feeding
Time frame: Through study completion, an average of 20 days
Perceived maternal parental self-efficacy
Time frame: Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization
Postnatal depression
Time frame: Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization
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 4 Mar 2022.
- Background: PubMed 26908962Chan GJ, Labar AS, Wall S, Atun R. Kangaroo mother care: a systematic review of barriers and enablers. Bull World Health Organ. 2016 Feb 1;94(2):130-141J. doi: 10.2471/BLT.15.157818. Epub 2015 Dec 3.
- Background: PubMed 28334033Premji SS, Currie G, Reilly S, Dosani A, Oliver LM, Lodha AK, Young M. A qualitative study: Mothers of late preterm infants relate their experiences of community-based care. PLoS One. 2017 Mar 23;12(3):e0174419. doi: 10.1371/journal.pone.0174419. eCollection 2017.
- Background: PubMed 24976830Rangey PS, Sheth M. Comparative Effect of Massage Therapy versus Kangaroo Mother Care on Body Weight and Length of Hospital Stay in Low Birth Weight Preterm Infants. Int J Pediatr. 2014;2014:434060. doi: 10.1155/2014/434060. Epub 2014 May 25.
- Background: PubMed 25803213Holditch-Davis D, White-Traut R, Levy J, Williams KL, Ryan D, Vonderheid S. Maternal satisfaction with administering infant interventions in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2013 Nov-Dec;42(6):641-54. doi: 10.1111/1552-6909.12255.
- Background: PubMed 31059673Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
- Background: PubMed 31916144Vargas-Porras C, Roa-Diaz ZM, Barnes C, Adamson-Macedo EN, Ferre-Grau C, De Molina-Fernandez MI. Psychometric Properties of the Spanish Version of the Perceived Maternal Parenting Self-efficacy (PMP S-E) Tool for Primiparous Women. Matern Child Health J. 2020 May;24(5):537-545. doi: 10.1007/s10995-019-02860-y.
- Background: PubMed 32271625Stuebe A. Should Infants Be Separated from Mothers with COVID-19? First, Do No Harm. Breastfeed Med. 2020 May;15(5):351-352. doi: 10.1089/bfm.2020.29153.ams. Epub 2020 Apr 9. No abstract available.
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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.
Lucy Vesga Gualdron, Professor study director
Universidad Nacional de Colombia
Fred Manrique Abril, Professor study director
Universidad Nacional de Colombia
Nubia Castiblanco Lopez, PhD student principal investigator
Universidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Baby Massage in people with Premature and Low Birth Weight, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 6 inclusion and 7 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 4 Mar 2022. 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 Colombia. 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?
weight (time frame: Through study completion, an average of 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908332, which also lists 7 linked publications.
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 4 Mar 2022.