Cobedding in Daily Weight Gain of Neonate Twins
This study has suspended participant recruitment.
(Enrollment terminated (64 patients included) but study continues (2 years of follow-up for one secondary objective))
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01480856
First received: November 25, 2011
Last updated: December 7, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Preterm Newborn Twins |
Procedure: Cobedding Procedure: Single-bedding |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins |
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]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:
- cardiorespiratory stability [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: Yes ]cardiorespiratory stability
- Thermoregulation [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: Yes ]Thermoregulation
- parents well-being estimated through questionnaires [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]parents well-being estimated through questionnaires
- newborns comfort [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]newborns comfort
- stop date of parenteral nutrition [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]stop date of parenteral nutrition
- date of removal of central catheter [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]date of removal of central catheter
- date of removal of nasogastric catheter [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]date of removal of nasogastric catheter
- stop date of oxygenotherapy [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]stop date of oxygenotherapy
- neuromotor development estimated by "Brunet Lezine" test at 2 years old [ Time Frame: 2 years ] [ Designated as safety issue: No ]neuromotor development estimated by "Brunet Lezine" test at 2 years old
- Hospitalization time length [ Time Frame: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks ] [ Designated as safety issue: No ]Hospitalization time length
| Enrollment: | 64 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | up to 4 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01480856 History of Changes |
| Other Study ID Numbers: | 08/2-H |
| Study First Received: | November 25, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Additional relevant MeSH terms:
|
Weight Gain Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013