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Completed

NCT Number: NCT01480856

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.

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Key information

Conditions

Preterm Newborn Twins

Age range

Up to 4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitary Hospital Center

Nantes, Loire atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cobedding

Procedure

Newborn twins are settled in a singe bed: this is cobedding

Single-bedding

Procedure

Newborn twins are settled in two single beds : this is single-bedding

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins

Acronym: Cobedding

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Nov 29, 2011
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.