Other Preterm InfantsNCT02231801
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
An observational study of Other Preterm Infants, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. Read more about this study
- Who is it for?
- Ages 30 to 35 weeks
- Conditions the study is for
- Other Preterm Infants
- What is being tested?
- Mother-Infant Dyad
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2015
- 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 30 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7 weeks gestational age to 34 6/7 weeks gestation age.
Who may be able to join
- inborn at Mount Sinai
- gestational age between 30 0/7 weeks and 34 6/7 weeks gestation
- only one infant of a multiple gestation
- plan by family to do kangaroo care during NICU stay
Who cannot join
- outborn infants
- gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
- other infants of multiple gestation (see inclusion criteria)
- any major congenital anomalies
- sepsis and/or any other serious clinical complication precluding kangaroo care
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.
Read the detailed description
The goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.
- Conditions
- Other Preterm Infants
- Being tested
- Mother-Infant Dyad
- Keywords
- Preterm, Kangaroo Care, Skin-to-Skin, Vital Sign, Heart Rate, Respiratory Rate, Oxygen Saturation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-Infant DyadBehavioural
Also called Kangaroo Care
Skin-to-skin holding of preterm infants by their mothers
| Study group | Role | What they receive |
|---|---|---|
| Mother-Infant Dyad | Skin-to-skin holding of preterm infants by their mothers Receives: Behavioral: Mother-Infant Dyad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured: up to 30 minutes
Secondary outcomes (2)
Respiratory Rate
Measured: up to 30 minutes
Oxygen Saturation
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Holzman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231801
- Sponsor's protocol ID
- GCO 14-1323
- Other IDs
- PD14-03941
- Status last verified
- Dec 2015
- First submitted
- 2 Sep 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants
- ClinicalTrials.gov ID
- NCT02231801
- Acronym / sponsor ID
- GCO 14-1323
- Conditions
- Other Preterm Infants
- Keywords
- Preterm, Kangaroo Care, Skin-to-Skin, Vital Sign, Heart Rate, Respiratory Rate, Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Sep 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.
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.
Detailed description
The goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-Infant Dyad | – | Behavioral: Mother-Infant DyadSkin-to-skin holding of preterm infants by their mothers |
Who may qualify
- Ages
- 30 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7 weeks gestational age to 34 6/7 weeks gestation age.
Key inclusion criteria (4 listed)
- inborn at Mount Sinai
- gestational age between 30 0/7 weeks and 34 6/7 weeks gestation
- only one infant of a multiple gestation
- plan by family to do kangaroo care during NICU stay
Key exclusion criteria (5 listed)
- outborn infants
- gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
- other infants of multiple gestation (see inclusion criteria)
- any major congenital anomalies
- sepsis and/or any other serious clinical complication precluding kangaroo care
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 |
|---|---|---|
| Mother-Infant DyadAlso: Kangaroo CareSkin-to-skin holding of preterm infants by their mothers | Behavioural | Mother-Infant Dyad |
Primary outcome
Heart Rate
Time frame: up to 30 minutes
2 secondary outcomes
Respiratory Rate
Time frame: up to 30 minutes
Oxygen Saturation
Time frame: up to 30 minutes
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 31 Dec 2015.
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
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.
Ian Holzman, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Other Preterm Infants, run by Icahn School of Medicine at Mount Sinai 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 31 Dec 2015. 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?
Heart Rate (time frame: up to 30 minutes). 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 31 Dec 2015.