Preterm Newborn Twins
Conditions
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.
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.
Interventions
PROCEDURECobedding
Newborn twins are settled in a singe bed: this is cobedding
PROCEDURESingle-bedding
Newborn twins are settled in two single beds : this is single-bedding
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | cardiorespiratory stability |
| Thermoregulation | patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks | Thermoregulation |
| parents well-being estimated through questionnaires | 5 weeks | parents well-being estimated through questionnaires |
| 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 | newborns comfort |
| 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 | stop date of parenteral nutrition |
| 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 central 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 | date of removal of nasogastric catheter |
| 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 | stop date of oxygenotherapy |
| neuromotor development estimated by "Brunet Lezine" test at 2 years old | 2 years | neuromotor development estimated by "Brunet Lezine" test at 2 years old |
| 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 | Hospitalization time length |
Countries
France
Outcome results
None listed