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Cobedding in Daily Weight Gain of Neonate Twins (Cobedding)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480856
First Posted: November 29, 2011
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
November 25, 2011
November 29, 2011
October 15, 2014
September 2008
January 2012   (Final data collection date for primary outcome measure)
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
to compare 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
Complete list of historical versions of study NCT01480856 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • parents well-being estimated through questionnaires [ Time Frame: 5 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    stop date of oxygenotherapy
  • 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
  • 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
  • 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
Not Provided
Not Provided
 
Cobedding in Daily Weight Gain of Neonate Twins
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Preterm Newborn Twins
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2014
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 4 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01480856
08/2-H
Yes
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP