Cobedding in Daily Weight Gain of Neonate Twins

NCT ID: NCT01480856

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Newborn Twins

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cobedding

Newborn twins are settled in a single bed : this is cobedding

Group Type ACTIVE_COMPARATOR

Cobedding

Intervention Type PROCEDURE

Newborn twins are settled in a singe bed: this is cobedding

Single -bedding

Newborn twins are settled in two beds : this is single-bedding

Group Type PLACEBO_COMPARATOR

Single-bedding

Intervention Type PROCEDURE

Newborn twins are settled in two single beds : this is single-bedding

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cobedding

Newborn twins are settled in a singe bed: this is cobedding

Intervention Type PROCEDURE

Single-bedding

Newborn twins are settled in two single beds : this is single-bedding

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -


* safety reasons
* prolonged lack of comfort clinically harmful for the newborn as per investigator conclusion.
Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitary Hospital Center

Nantes, Loire atlantique, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/2-H

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.