Cobedding in Daily Weight Gain of Neonate Twins (Cobedding)

October 14, 2014 updated by: Nantes University Hospital

Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins

Cobedding consists of associating twins in a common cocoon in order to maintain links developed in utero and reduce the stress of premature birth. The aim of this randomized, controlled prospective study is to compare efficacy (in term of newborn daily weight gain) and safety of cobedding versus single-bedding of preterm twins.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Randomization will occur during the first 96 hours after birth.Twins randomized in the cobedding arm will be kept in the same cocoon until maximum 37 amenorrhea weeks. Each day, parameters (weight gain, …) will be registered.At two years old, neuromotor development of twins will be estimated by Brunet-Lezine test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Loire atlantique
      • Nantes, Loire atlantique, France, 44093
        • Universitary Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 4 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At time of inclusion, twins must have been separated since less than 96h following birth.
  • twins born between 30 to 34 weeks of gestation
  • no severe congenital pathology
  • hospitalized at the intensive neonates care unit
  • Parents having given their non-opposition to this study within the 96 hours following twins birth -Time length of cobedding estimated by the investigator to be of three weeks -

Exclusion Criteria:

Inclusion criteria not fulfilled

  • safety reasons
  • prolonged lack of comfort clinically harmful for the newborn as per investigator conclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cobedding
Newborn twins are settled in a single bed : this is cobedding
Procedure: Cobedding
Newborn twins are settled in a singe bed: this is cobedding
Placebo Comparator: Single -bedding
Newborn twins are settled in two beds : this is single-bedding
Procedure: Single-bedding
Newborn twins are settled in two single beds : this is single-bedding

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cardiorespiratory stability
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
cardiorespiratory stability
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Thermoregulation
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Thermoregulation
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
parents well-being estimated through questionnaires
Time Frame: 5 weeks
parents well-being estimated through questionnaires
5 weeks
newborns comfort
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
newborns comfort
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
stop date of parenteral nutrition
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
stop date of parenteral nutrition
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
date of removal of central catheter
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
date of removal of central catheter
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
date of removal of nasogastric catheter
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
date of removal of nasogastric catheter
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
stop date of oxygenotherapy
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
stop date of oxygenotherapy
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
neuromotor development estimated by "Brunet Lezine" test at 2 years old
Time Frame: 2 years
neuromotor development estimated by "Brunet Lezine" test at 2 years old
2 years
Hospitalization time length
Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Hospitalization time length
patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08/2-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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