Cobedding in Daily Weight Gain of Neonate Twins

This study has suspended participant recruitment.

(Enrollment terminated (64 patients included) but study continues (2 years of follow-up for one secondary objective))

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01480856

First received: November 25, 2011

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 25, 2011
Last Updated Date	December 7, 2012
Start Date ^ICMJE	September 2008
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2012)	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 ] [ Designated as safety issue: No ] The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
Original Primary Outcome Measures ^ICMJE (submitted: November 28, 2011)	to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins [ Designated as safety issue: No ] The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
Change History	Complete list of historical versions of study NCT01480856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2012)	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 ] [ Designated as safety issue: Yes ] cardiorespiratory stability 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 ] [ Designated as safety issue: Yes ] Thermoregulation parents well-being estimated through questionnaires [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] parents well-being estimated through questionnaires 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 ] [ Designated as safety issue: No ] newborns comfort 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 ] [ Designated as safety issue: No ] stop date of parenteral nutrition 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 ] [ Designated as safety issue: No ] date of removal of central catheter 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 ] [ Designated as safety issue: No ] date of removal of nasogastric catheter 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 ] [ Designated as safety issue: No ] stop date of oxygenotherapy neuromotor development estimated by "Brunet Lezine" test at 2 years old [ Time Frame: 2 years ] [ Designated as safety issue: No ] neuromotor development estimated by "Brunet Lezine" test at 2 years old 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 ] [ Designated as safety issue: No ] Hospitalization time length
Original Secondary Outcome Measures ^ICMJE (submitted: November 28, 2011)	cardiorespiratory stability [ Designated as safety issue: Yes ] cardiorespiratory stability Thermoregulation [ Designated as safety issue: Yes ] Thermoregulation parents well-being estimated through questionnaires [ Designated as safety issue: No ] parents well-being estimated through questionnaires newborns comfort [ Designated as safety issue: No ] newborns comfort stop date of parenteral nutrition [ Designated as safety issue: No ] stop date of parenteral nutrition date of removal of central catheter [ Designated as safety issue: No ] date of removal of central catheter date of removal of nasogastric catheter [ Designated as safety issue: No ] date of removal of nasogastric catheter stop date of oxygenotherapy [ Designated as safety issue: No ] stop date of oxygenotherapy neuromotor development estimated by "Brunet Lezine" test at 2 years old [ Designated as safety issue: No ] neuromotor development estimated by "Brunet Lezine" test at 2 years old Hospitalization time length [ Designated as safety issue: No ] Hospitalization time length
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cobedding in Daily Weight Gain of Neonate Twins
Official Title ^ICMJE	Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Preterm Newborn Twins
Intervention ^ICMJE	Procedure: Cobedding Newborn twins are settled in a singe bed: this is cobedding Procedure: Single-bedding Newborn twins are settled in two single beds : this is single-bedding
Study Arm (s)	Active Comparator: Cobedding Newborn twins are settled in a single bed : this is cobedding Intervention: Procedure: Cobedding Placebo Comparator: Single -bedding Newborn twins are settled in two beds : this is single-bedding Intervention: Procedure: Single-bedding
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE	64
Estimated Completion Date	January 2014
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 4 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01480856
Other Study ID Numbers ^ICMJE	08/2-H
Has Data Monitoring Committee	Yes
Responsible Party	Nantes University Hospital
Study Sponsor ^ICMJE	Nantes University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nantes University Hospital
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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