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Cobedding in Daily Weight Gain of Neonate Twins (Cobedding)

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ClinicalTrials.gov Identifier: NCT01480856
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Preterm Newborn Twins Procedure: Cobedding Procedure: Single-bedding

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 : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins
Study Start Date : September 2008
Primary Completion Date : January 2012
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cobedding
Newborn twins are settled in a single bed : this is cobedding
Procedure: Cobedding
Newborn twins are settled in a singe bed: this is cobedding
Placebo Comparator: Single -bedding
Newborn twins are settled in two beds : this is single-bedding
Procedure: Single-bedding
Newborn twins are settled in two single beds : this is single-bedding



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. parents well-being estimated through questionnaires [ Time Frame: 5 weeks ]
    parents well-being estimated through questionnaires

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480856


Locations
France
Universitary Hospital Center
Nantes, Loire atlantique, France, 44093
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01480856     History of Changes
Other Study ID Numbers: 08/2-H
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms