Cobedding in Daily Weight Gain of Neonate Twins (Cobedding)

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Newborn Twins
• Intervention / Treatment: Procedure: Cobedding; Procedure: Single-bedding

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Loire atlantique
    • Nantes, Loire atlantique, France, 44093
      • Universitary Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 25, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: 08/2-H