Cobedding in Daily Weight Gain of Neonate Twins

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Preterm Newborn Twins

Intervention / Treatment
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* Procedure: Cobedding
* Procedure: Single-bedding


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 4 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cobedding<br>Newborn twins are settled in a single bed : this is cobedding | Procedure: Cobedding<br>* Newborn twins are settled in a singe bed: this is cobedding<br>|
| Placebo Comparator: Single -bedding<br>Newborn twins are settled in two beds : this is single-bedding | Procedure: Single-bedding<br>* Newborn twins are settled in two single beds : this is single-bedding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiorespiratory stability | cardiorespiratory stability | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks | 
| Thermoregulation | Thermoregulation | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks | 
| parents well-being estimated through questionnaires | parents well-being estimated through questionnaires | 5 weeks | 
| newborns comfort | newborns comfort | 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 | stop date of parenteral nutrition | 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 central catheter | 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 | date of removal of nasogastric catheter | 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 | stop date of oxygenotherapy | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks | 
| neuromotor development estimated by Brunet Lezine test at 2 years old | neuromotor development estimated by Brunet Lezine test at 2 years old | 2 years | 
| Hospitalization time length | Hospitalization time length | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks |