Cobedding in Daily Weight Gain of Neonate Twins

Nantes University Hospital (NUH)

Status: Completed

Conditions: Preterm Newborn Twins

Treatments: Procedure: Single-bedding; Procedure: Cobedding

Study type: Interventional

Funder types: Other

Identifiers

NCT01480856

08/2-H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: Under 4 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups, including a placebo group

Cobedding

Active Comparator group

Description:

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

Treatment:

Procedure: Cobedding

Single -bedding

Placebo Comparator group

Description:

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

Treatment:

Procedure: Single-bedding