Neonatal Temperature; Kangaroo Mother CarePhase 4NCT02645526
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
A Phase 4 study testing Woolen cap in people with Neonatal Temperature; Kangaroo Mother Care, run by University Hospital Padova at 1 site in Italy.
Trial summary
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC). Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Neonatal Temperature; Kangaroo Mother Care
- What is being tested?
- Woolen cap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Oct 2016
- Phase
- Phase 4
- 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 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight <2500 g (and)
- Candidate to KMC treatment (and)
- Parental consent; a written informed consent will be obtained by a member of the neonatal - Team involved in the study from a parent or guardian before KMC treatment
Who cannot join
- Major congenital malformations
- Twins
- Parental refusal to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).
Read the detailed description
Background: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited.
Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect temperature control during KMC remains to be established.
In the hospitals participating to the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap.
Objective: The aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.
Methods: This is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight <2500 g and candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome measure will be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week of life. In all participants, axillary temperature will be measured with a digital thermometer 4 times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.
- Being tested
- Woolen cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woolen capOther
| Study group | Role | What they receive |
|---|---|---|
| KMC with woolen cap | Experimental | In this group, the head of the patients will be covered with a woolen cap during KMC. Receives: Other: Woolen cap |
| KMC without woolen cap | No intervention | In this group, the head of the patients will be uncovered during KMC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal temperature in the normal range (36.5-37.5°C) in course of KMC treatment.
Measured: First week of life.
Secondary outcomes (4)
Number of Participants With Sepsis defined as Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Measured: Through study completion, an average of 2 weeks.
Number of participants died during hospital stay.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 weeks.
Rate of growth (g/kg/die) during hospital stay.
Measured: From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks.
Age at discharge.
Measured: From date of birth until the date discharge, whichever came first, assessed up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal Temperature; Kangaroo Mother CareStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Doctors with Africa - Collegio Universitario Aspiranti Medici Missionari (CUAMM)
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645526
- Sponsor's protocol ID
- CUAMMcap
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19.
PubMed 24853593Boundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, Kajeepeta S, Wall S, Chan GJ. Kangaroo Mother Care and Neonatal Outcomes: A Meta-analysis. Pediatrics. 2016 Jan;137(1):e20152238. doi: 10.1542/peds.2015-2238. Epub 2015 Dec 23.
PubMed 26702029Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
PubMed 22382859Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
PubMed 26477415Cavallin F, Segafredo G, Pizzol D, Massavon W, Lusiani M, Wingi O, De Vivo M, Da Dalt L, Boscardin C, Manenti F, Putoto G, Trevisanuto D; CAP-KMC Group. Thermal Effect of a Woolen Cap in Low Birth Weight Infants During Kangaroo Care. Pediatrics. 2018 Jun;141(6):e20173073. doi: 10.1542/peds.2017-3073. Epub 2018 May 22.
PubMed 29789445Trevisanuto D, Putoto G, Pizzol D, Serena T, Manenti F, Varano S, Urso E, Massavon W, Tsegaye A, Wingi O, Onapa E, Segafredo G, Cavallin F. Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial. Trials. 2016 May 26;17(1):265. doi: 10.1186/s13063-016-1387-0.
PubMed 27229315
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
- ClinicalTrials.gov ID
- NCT02645526
- Acronym / sponsor ID
- CUAMMcap
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- Doctors with Africa - Collegio Universitario Aspiranti Medici Missionari (CUAMM)
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jan 2016 (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.
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).
Detailed description
Background: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited.
Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect temperature control during KMC remains to be established.
In the hospitals participating to the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap.
Objective: The aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.
Methods: This is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight <2500 g and candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome measure will be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week of life. In all participants, axillary temperature will be measured with a digital thermometer 4 times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KMC with woolen cap | Experimental | Other: Woolen capIn this group, the head of the patients will be covered with a woolen cap during KMC. |
| KMC without woolen cap | No intervention | –In this group, the head of the patients will be uncovered during KMC. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight <2500 g (and)
- Candidate to KMC treatment (and)
- Parental consent; a written informed consent will be obtained by a member of the neonatal - Team involved in the study from a parent or guardian before KMC treatment
Key exclusion criteria (3 listed)
- Major congenital malformations
- Twins
- Parental refusal to participate to the study
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 |
|---|---|---|
| Woolen cap | Other | KMC with woolen cap |
Primary outcome
Neonatal temperature in the normal range (36.5-37.5°C) in course of KMC treatment.
Time frame: First week of life.
4 secondary outcomes
Number of Participants With Sepsis defined as Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: Through study completion, an average of 2 weeks.
Number of participants died during hospital stay.
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 weeks.
Rate of growth (g/kg/die) during hospital stay.
Time frame: From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks.
Age at discharge.
Time frame: From date of birth until the date discharge, whichever came first, assessed up to 2 weeks.
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 Jan 2017.
- Background: PubMed 24853593Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19.
- Background: PubMed 26702029Boundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, Kajeepeta S, Wall S, Chan GJ. Kangaroo Mother Care and Neonatal Outcomes: A Meta-analysis. Pediatrics. 2016 Jan;137(1):e20152238. doi: 10.1542/peds.2015-2238. Epub 2015 Dec 23.
- Background: PubMed 22382859Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
- Background: PubMed 26477415Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
- Derived from this study: PubMed 29789445Cavallin F, Segafredo G, Pizzol D, Massavon W, Lusiani M, Wingi O, De Vivo M, Da Dalt L, Boscardin C, Manenti F, Putoto G, Trevisanuto D; CAP-KMC Group. Thermal Effect of a Woolen Cap in Low Birth Weight Infants During Kangaroo Care. Pediatrics. 2018 Jun;141(6):e20173073. doi: 10.1542/peds.2017-3073. Epub 2018 May 22.
- Derived from this study: PubMed 27229315Trevisanuto D, Putoto G, Pizzol D, Serena T, Manenti F, Varano S, Urso E, Massavon W, Tsegaye A, Wingi O, Onapa E, Segafredo G, Cavallin F. Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial. Trials. 2016 May 26;17(1):265. doi: 10.1186/s13063-016-1387-0.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Woolen cap in people with Neonatal Temperature; Kangaroo Mother Care, run by University Hospital Padova at 1 site in Italy.
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 3 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 Jan 2017. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Neonatal temperature in the normal range (36.5-37.5°C) in course of KMC treatment. (time frame: First week of life.). 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 NCT02645526, which also lists 6 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 19 Jan 2017.