Cobedding in Daily Weight Gain of Neonate Twins

Preterm Newborn Twins Clinical Trial

— Cobedding  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480856
• Other study ID #: 08/2-H
• Status: Completed
• Phase: N/A
• First received: November 25, 2011
• Last updated: October 14, 2014
• Start date: September 2008
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Preterm Newborn Twins
• Weight Gain

Intervention

Procedure:
• Cobedding
Newborn twins are settled in a singe bed: this is cobedding
• Single-bedding
Newborn twins are settled in two single beds : this is single-bedding

Locations

Country	Name	City	State
France	Universitary Hospital Center	Nantes	Loire atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	parents well-being estimated through questionnaires	parents well-being estimated through questionnaires	5 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	neuromotor development estimated by "Brunet Lezine" test at 2 years old	neuromotor development estimated by "Brunet Lezine" test at 2 years old	2 years	No
Secondary	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	No