Premature BirthNCT00418106
Kangaroo Holding Effects on Breast Milk
An observational study of Premature Birth, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the… Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2006
- Phase
- Observational
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mothers of preterm infants
Who may be able to join
- Birth weight </= 2000 grams
- Gestational age 26-34 weeks at birth
- Medically stable at start of study
- < 14 days old at start of study
Who cannot join
- Infants receiving phototherapy
- Suspected congenital abnormalities
- Overwhelming sepsis
- Cardiac Abnormalities
- Suspected infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Kangaroo Holding Effects on Breast Milk Composition
Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.
Hypotheses:
- There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions
- There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.
Read the detailed description
This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.
- Conditions
- Premature Birth
- Keywords
- Premature birth, Pumping breast milk, Kangaroo holding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mothers who are pumping breast milk and who are willing to kangaroo hold their infant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk production and composition
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startNov 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Investigators
- Amy N. Johnson, DNSc, RNC, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418106
- Sponsor's protocol ID
- 24211
- Status last verified
- Jan 2008
- First submitted
- 2 Jan 2007
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Kangaroo Holding Effects on Breast Milk Composition
- ClinicalTrials.gov ID
- NCT00418106
- Acronym / sponsor ID
- 24211
- Conditions
- Premature Birth
- Keywords
- Premature birth, Pumping breast milk, Kangaroo holding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- Nov 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 4 Jan 2007 (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.
Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.
Hypotheses:
- There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions
- There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.
Detailed description
This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mothers who are pumping breast milk and who are willing to kangaroo hold their infant. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mothers of preterm infants
Key inclusion criteria (4 listed)
- Birth weight </= 2000 grams
- Gestational age 26-34 weeks at birth
- Medically stable at start of study
- < 14 days old at start of study
Key exclusion criteria (5 listed)
- Infants receiving phototherapy
- Suspected congenital abnormalities
- Overwhelming sepsis
- Cardiac Abnormalities
- Suspected infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast milk production and composition
Time frame: 1 week
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 18 Jan 2008.
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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.
Amy N. Johnson, DNSc, RNC principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Christiana Care Health Services at 1 site in United States.
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 5 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 18 Jan 2008. 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 United States. 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?
Breast milk production and composition (time frame: 1 week). 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 18 Jan 2008.