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

November 25, 2011
December 7, 2012
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 ] [ 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
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
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 ] [ 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
  • 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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Suspended
64
January 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.
Both
up to 4 Days
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01480856
08/2-H
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
December 2012

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