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Cobedding in Daily Weight Gain of Neonate Twins (Cobedding)

Primary Purpose

Preterm Newborn Twins

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cobedding
Single-bedding
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Newborn Twins

Eligibility Criteria

undefined - 4 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universitary Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cobedding

Single -bedding

Arm Description

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

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

Outcomes

Primary Outcome Measures

Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins

Secondary Outcome Measures

cardiorespiratory stability
cardiorespiratory stability
Thermoregulation
Thermoregulation
parents well-being estimated through questionnaires
parents well-being estimated through questionnaires
newborns comfort
newborns comfort
stop date of parenteral nutrition
stop date of parenteral nutrition
date of removal of central catheter
date of removal of central catheter
date of removal of nasogastric catheter
date of removal of nasogastric catheter
stop date of oxygenotherapy
stop date of oxygenotherapy
neuromotor development estimated by "Brunet Lezine" test at 2 years old
neuromotor development estimated by "Brunet Lezine" test at 2 years old
Hospitalization time length
Hospitalization time length

Full Information

First Posted
November 25, 2011
Last Updated
October 14, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01480856
Brief Title
Cobedding in Daily Weight Gain of Neonate Twins
Acronym
Cobedding
Official Title
Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Newborn Twins

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cobedding
Arm Type
Active Comparator
Arm Description
Newborn twins are settled in a single bed : this is cobedding
Arm Title
Single -bedding
Arm Type
Placebo Comparator
Arm Description
Newborn twins are settled in two beds : this is single-bedding
Intervention Type
Procedure
Intervention Name(s)
Cobedding
Intervention Description
Newborn twins are settled in a singe bed: this is cobedding
Intervention Type
Procedure
Intervention Name(s)
Single-bedding
Intervention Description
Newborn twins are settled in two single beds : this is single-bedding
Primary Outcome Measure Information:
Title
Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
Description
The main objective of this study is to compare 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
Secondary Outcome Measure Information:
Title
cardiorespiratory stability
Description
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
Title
Thermoregulation
Description
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
Title
parents well-being estimated through questionnaires
Description
parents well-being estimated through questionnaires
Time Frame
5 weeks
Title
newborns comfort
Description
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
Title
stop date of parenteral nutrition
Description
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
Title
date of removal of central catheter
Description
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
Title
date of removal of nasogastric catheter
Description
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
Title
stop date of oxygenotherapy
Description
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
Title
neuromotor development estimated by "Brunet Lezine" test at 2 years old
Description
neuromotor development estimated by "Brunet Lezine" test at 2 years old
Time Frame
2 years
Title
Hospitalization time length
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universitary Hospital Center
City
Nantes
State/Province
Loire atlantique
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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Cobedding in Daily Weight Gain of Neonate Twins

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