Clinical trial NCT01480856: Cobedding in Daily Weight Gain of Neonate Twins
Official title: Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Newborn Twins
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 64
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Secondary outcomes:
measure: cardiorespiratory stability
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: Thermoregulation
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: parents well-being estimated through questionnaires
timeFrame: 5 weeks
measure: newborns comfort
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: stop date of parenteral nutrition
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: date of removal of central catheter
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: date of removal of nasogastric catheter
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: stop date of oxygenotherapy
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
measure: neuromotor development estimated by "Brunet Lezine" test at 2 years old
timeFrame: 2 years
measure: Hospitalization time length
timeFrame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Universitary Hospital Center
state: Loire atlantique
Study officials:
References: