Low Birth Weight Among NeonatesPhase 3NCT02085382
Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates
A Phase 3 study testing Kangaroo Mother Care and Conventional Mother Care in people with Low Birth Weight Among Neonates, run by University of the Philippines at 1 site in Philippines.
Trial summary
A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight Among Neonates
- What is being tested?
- Kangaroo Mother Care and Conventional Mother Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePhilippines
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 3
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
- normal heart rate (120-160 bpm), normal blood pressure per age
- no apnea
- no intravenous lines or with well-secured peripheral line
- no sepsis
- no emerging signs of sepsis
- on IV antibiotic therapy but clinically stable
- can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.
Who cannot join
- neonates with chromosomal and life threatening congenital anomalies, who were severally ill
- whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines Manila
Manila, National Capital Region, 1000
About this study
Official title: A Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Low Birth Weight Neonates Admitted in Level II Neonatal Intensive Care Unit of the Philippine General Hospital
A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.
Read the detailed description
A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.
- Conditions
- Low Birth Weight Among Neonates
- Being tested
- Kangaroo Mother Care, Conventional Mother Care
- Keywords
- Kangaroo Mother Care(KMC), Low-birth weight, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareProcedure or surgery
The infants were placed on continuous skin to skin contact between the mother and the baby as soon as possible. The mother kept her newborn infant between the breast, in close contact with her body and covered with the kangaroo tube. Infants wore diaper and a cap during the procedure. Breastfeeding was the standard feeding method.
When the baby was not in KMC, the baby was placed in the bassinet under warm lamp, if needed, adequately clothed and covered.
Conventional Mother CareProcedure or surgery
This is generally included: an artificial warming system (heated room overhead lamp warmers). Breastfeeding was also the standard feeding method but if indicated, babies can also be fed through tube or cup feeding. The mothers were allowed to visit their babies anytime but skin to skin contact was not allowed.
Babies in both groups were monitored hourly. Their heart rate, respiratory rate and temperature were monitored and recorded. Any untoward events like hypothermia, hypoglycemia, apnea, signs of sepsis, and feeding problems were also noted.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Mother Care Group | Other | Mothers in the KMC group were oriented in detail about KMC procedure. The mothers provided skin to skin contact using a specially tailored "kangaroo tube" made of soft flannel cloth. The mothers were encouraged to keep the baby in KMC as long as possible during the day and night for an accumulated time of at least 6 hours per day. The duration of the kangaroo care by each of the mother were recorded and tallied accordingly. Receives: Procedure: Kangaroo Mother Care |
| Conventional Mother Care | Other | Conventional method of care was the routine care offered in the neonatal unit to low birth weight infants. Receives: Procedure: Conventional Mother Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Birth Weight
Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight Among NeonatesStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Faye S De Ocampo, Medical Doctor, Principal investigator, Department of Pediatrics College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085382
- Sponsor's protocol ID
- NIH 2011-014
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Low Birth Weight Neonates Admitted in Level II Neonatal Intensive Care Unit of the Philippine General Hospital
- ClinicalTrials.gov ID
- NCT02085382
- Acronym / sponsor ID
- NIH 2011-014
- Conditions
- Low Birth Weight Among Neonates
- Keywords
- Kangaroo Mother Care(KMC), Low-birth weight, neonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.
Detailed description
A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Mother Care Group | Other | Procedure: Kangaroo Mother CareMothers in the KMC group were oriented in detail about KMC procedure. The mothers provided skin to skin contact using a specially tailored "kangaroo tube" made of soft flannel cloth. The mothers were encouraged to keep the baby in KMC as long as possible during the day and night for an accumulated time of at least 6 hours per day. The duration of the kangaroo care by each of the mother were recorded and tallied accordingly. |
| Conventional Mother Care | Other | Procedure: Conventional Mother CareConventional method of care was the routine care offered in the neonatal unit to low birth weight infants. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
- normal heart rate (120-160 bpm), normal blood pressure per age
- no apnea
- no intravenous lines or with well-secured peripheral line
- no sepsis
Key exclusion criteria (2 listed)
- neonates with chromosomal and life threatening congenital anomalies, who were severally ill
- whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.
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 Mother CareThe infants were placed on continuous skin to skin contact between the mother and the baby as soon as possible. The mother kept her newborn infant between the breast, in close contact with her body and covered with the kangaroo tube. Infants wore diaper and a cap during the procedure. Breastfeeding was the standard feeding method. When the baby was not in KMC, the baby was placed in the bassinet under warm lamp, if needed, adequately clothed and covered. | Procedure or surgery | Kangaroo Mother Care Group |
| Conventional Mother CareThis is generally included: an artificial warming system (heated room overhead lamp warmers). Breastfeeding was also the standard feeding method but if indicated, babies can also be fed through tube or cup feeding. The mothers were allowed to visit their babies anytime but skin to skin contact was not allowed. Babies in both groups were monitored hourly. Their heart rate, respiratory rate and temperature were monitored and recorded. Any untoward events like hypothermia, hypoglycemia, apnea, signs of sepsis, and feeding problems were also noted. | Procedure or surgery | Conventional Mother Care |
Primary outcome
Low Birth Weight
Time frame: 3 days
Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.
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 12 Mar 2014.
Related trials for Low Birth Weight Among Neonates
Not yet recruiting
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
Low Birth Weight Among Neonates
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.
Faye S De Ocampo, Medical Doctor principal investigator
Department of Pediatrics College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kangaroo Mother Care and Conventional Mother Care in people with Low Birth Weight Among Neonates, run by University of the Philippines at 1 site in Philippines.
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 8 inclusion and 2 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 12 Mar 2014. 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 Philippines. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Low Birth Weight (time frame: 3 days). 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 12 Mar 2014.