Cobedding in Daily Weight Gain of Neonate Twins

Not Applicable

Completed

• Conditions: Preterm Newborn Twins
• Interventions: Procedure: Cobedding; Procedure: Single-bedding

• Registration Number: NCT01480856
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Primary Completion: 2012-01
• Study Completion: 2014-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cobedding	Cobedding	Newborn twins are settled in a single bed : this is cobedding
Single -bedding	Single-bedding	Newborn twins are settled in two beds : this is single-bedding

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Universitary Hospital Center; 🇫🇷 Nantes, Loire atlantique, France