Cobedding in Daily Weight Gain of Neonate Twins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01480856
First received: November 25, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
Preterm Newborn Twins
Procedure: Cobedding
Procedure: Single-bedding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 64
Study Start Date: September 2008
Study Completion Date: February 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 4 Days
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480856

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

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01480856     History of Changes
Other Study ID Numbers: 08/2-H
Study First Received: November 25, 2011
Last Updated: October 14, 2014
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on October 22, 2014