Preterm Newborn TwinsCobeddingNCT01480856
Cobedding in Daily Weight Gain of Neonate Twins
A study testing Cobedding and Single-bedding in people with Preterm Newborn Twins, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Newborn Twins
- What is being tested?
- Cobedding and Single-bedding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 -
- safety reasons
- prolonged lack of comfort clinically harmful for the newborn as per investigator conclusion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Newborn Twins
- Being tested
- Cobedding, Single-bedding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobeddingProcedure or surgery
Newborn twins are settled in a singe bed: this is cobedding
Single-beddingProcedure or surgery
Newborn twins are settled in two single beds : this is single-bedding
| Study group | Role | What they receive |
|---|---|---|
| Cobedding | Active comparator | Newborn twins are settled in a single bed : this is cobedding Receives: Procedure: Cobedding |
| Single -bedding | Placebo comparator | Newborn twins are settled in two beds : this is single-bedding Receives: Procedure: Single-bedding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Secondary outcomes (10)
cardiorespiratory stability
cardiorespiratory stability
Measured: 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
Measured: 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
Measured: 5 weeks
newborns comfort
newborns comfort
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Hospitalization time length
Hospitalization time length
Measured: patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startSep 2008
- Primary completionJan 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Newborn TwinsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480856
- Sponsor's protocol ID
- BRD/08/02-H
- Acronym
- Cobedding
- Status last verified
- Oct 2014
- First submitted
- 25 Nov 2011
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Legrand A, Frondas A, Aubret F, Corre A, Flamant C, Simon L, Desrobert C, Roze JC. Randomised controlled trial shows that co-bedding twins may reduce birthweight recovery delay, parenteral nutrition weaning time and hospitalisation. Acta Paediatr. 2017 Dec;106(12):2055-2059. doi: 10.1111/apa.13885. Epub 2017 May 22. No abstract available.
PubMed 28436200
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins
- ClinicalTrials.gov ID
- NCT01480856
- Acronym / sponsor ID
- Cobedding / BRD/08/02-H
- Conditions
- Preterm Newborn Twins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobedding | Active comparator | Procedure: CobeddingNewborn twins are settled in a single bed : this is cobedding |
| Single -bedding | Placebo comparator | Procedure: Single-beddingNewborn twins are settled in two beds : this is single-bedding |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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 -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CobeddingNewborn twins are settled in a singe bed: this is cobedding | Procedure or surgery | Cobedding |
| Single-beddingNewborn twins are settled in two single beds : this is single-bedding | Procedure or surgery | Single -bedding |
Primary outcome
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
The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins
10 secondary outcomes
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
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
parents well-being estimated through questionnaires
Time frame: 5 weeks
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
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
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
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
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
neuromotor development estimated by "Brunet Lezine" test at 2 years old
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 28436200Legrand A, Frondas A, Aubret F, Corre A, Flamant C, Simon L, Desrobert C, Roze JC. Randomised controlled trial shows that co-bedding twins may reduce birthweight recovery delay, parenteral nutrition weaning time and hospitalisation. Acta Paediatr. 2017 Dec;106(12):2055-2059. doi: 10.1111/apa.13885. Epub 2017 May 22. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cobedding and Single-bedding in people with Preterm Newborn Twins, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.