Skin-to-skinNCT06154148
Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional
A study testing Sustained Diagonal Flexion positioning and Traditional prone position in people with Skin-to-skin and Preterm Birth, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the… Read more about this study
- Who is it for?
- Ages 24 hours to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Skin-to-skin, Preterm Birth
- What is being tested?
- Sustained Diagonal Flexion positioning and Traditional prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 30 Sep 2025
- 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 24 hours to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature infant born between 27 and 34 weeks of gestational age
- Aged between 24 hours and maximum 4 days at the beginning of the study
- Approval from the neonatologist in charge of the patient to participate in the study
- Informed consent of the parents to participate in the study
- At least one of the two parents must have a good knowledge of French.
Who cannot join
- Infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade III or IV)
- Infant or parent who requires or has required surgery during their neonatal stay
- Triplets
- Parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care
- Infant with an arterial line
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Neonatal Unit Hopital Erasme
Brussels, Anderlecht, 1070
Dorottya Kelen, MD, 025553430 ext. 53430, dorottya.kelen@erasme.ulb.ac.be
Laura Maroye, 025558103 ext. 58103, Laura.Maroye@erasme.ulb.ac.be
About this study
Official title: Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion (SDF) With Sling Versus Traditional Prone Position With Headband During Skin-to-skin Care Session
This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the daily duration of skin-to-skin contact.
Read the detailed description
This is a prospective, controlled, randomized, non-blinded trial, recruiting premature infants between 27- 34 weeks of gestational age during the first 4 days of life.
80 parent-infant dyads will be recruited in the Department of Neonatology (GA between 27 and 34 weeks) and randomly divided in two groups. Each dyads will be assigned to one of the two skin-to-skin positions.
The study aims to investigate if the sustained diagonal flexion method (SDF) provides additional benefits for both the child and their parents, such as increase in daily skin-to-skin time and its continuation after discharge.
The investigators will analyze the daily duration of skin-to-skin, the cardiorespiratory stability of the child (number of incidents recorded by standard monitoring), the presence of pain during: installation /skin-to-skin/ after the return to the incubator, the continuation of skin-to-skin, breastfeeding after discharge, the risk of postpartum depression in the mother, parental stress, joint mobility and muscle tension of the child and their parents, and also the comfort and satisfaction with the type of skin-to-skin.
- Conditions
- Skin-to-skin, Preterm Birth
- Being tested
- Sustained Diagonal Flexion positioning, Traditional prone position
- Keywords
- Kangaroo Care, Skin-to-skin, Sustained diagonal flexion, skin-to-skin contact time, Joint mobility and muscular tension assessment, Preterm, Family centered care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Diagonal Flexion positioningProcedure or surgery
Also called FDS
This position is a semi reclined positioning, the infant is off-center and semi-reclined on the mother's chest its body-axis is slightly flexed, with the limbs retracted in a preventive posture and the head in line with the body axis, moderately externally rotated hips in flexion-abduction, with adducted shoulders. The infant's head turns toward the mother's face and is located between the nipple and the clavicule. Their arms and legs are flexed,in a naturally adopted asymmetrical tonic neck posture, according to the infant's term and comfort. The infant is naked and positioned inside the mother's clothes.
Traditional prone positionProcedure or surgery
The infant is placed vertically between the mother's breasts firmly attached to the chest and below their clothes.
| Study group | Role | What they receive |
|---|---|---|
| Sustained Diagonal Flexion positioning | Experimental | This position is a semi reclined positioning, the premature infant is off-center and semi-reclined on the mother's chest its body-axis is slightly flexed, with the limbs retracted in a preventive posture and the head in line with the body axis, moderately externally rotated hips in flexion-abduction, with adducted shoulders. The infants's head turns toward the mother's face and is located between the nipple and the clavicle. Their arms and legs are flexed, in a naturally adopted asymmetrical tonic neck posture, according to the infants's term and comfort. The infant is naked and positioned inside the mother's clothes. Receives: Procedure: Sustained Diagonal Flexion positioning |
| Traditional prone position | Active comparator | The infants are placed vertically between the mother's breasts firmly attached to the chest and below their clothes. Receives: Procedure: Traditional prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily duration of skin-to-skin during postnatal hospitalisation
Investigate the effect of skin-to-skin position of premature infants in supported diagonal flexion (SDF) by a sling on daily duration of skin to skin contact during hospitalization (Measured in minutes per day. )
Measured: during hospitalisation
Continuation of skin-to-skin after discharge
Time spent in a sling by 6 months of age. (Measured in minutes per day)
Measured: 6 months
Secondary outcomes (9)
Breastfeeding at discharge and at 1, 3, 6 month of age
Breastfeeding at discharge and duration of breastfeeding after discharge; Continuation of breastfeeding (exclusive or mixed), use of breast pump and reasons for stopping breastfeeding (work - other) will be collected by telephone interview from parents at 1, 3 and 6 months after discharge.
Measured: 6 months
Cardiovascular stability of the infant
Occurrence of apnea, bradycardia, and desaturation episodes; Number of incidents will be recorded from the monitoring at installation, during the skin-to-skin time and during the de-installation (number of bradycardias, apneas, desaturations, hypothermia < 36°C). Any comments from the caregiver or parent will also be noted. (Measured in episodes/hour)
Measured: 3-12 weeks
Physiological parameters via Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score
Between day 3 - 7 of life, day 10 - 12 of life and day 18-22 of life a specific recording of the physiological parameters via the Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score will be carried out two hours before, during the first two hours, and two hours after the end of the intervention. The SCRIP score measure three parameters of the cardiorespiratory stability of the infants. (Score between 0-6, low score indicates instability, high score indicates stability.
Measured: 3-22 days
Physiological parameters via Newborn Infant Parasympathetic Evaluation (NIPE) scores
Between day 3 - 7 of life, day 10 - 12 of life and day 18-22 of life the NIPE (Newborn Infant Parasympathetic Evaluation) monitoring will be installed, the values taken will be those given 30 minutes before the skin-to-skin, the first hour of the skin-to-skin and 30 minutes after the skin-to-skin. The NIPE monitor provides an objective pain 'index' from 0 to 100. Lower indices reflect more pain, whereas higher indices indicate less pain.
Measured: 3-22 days
Comfort-Behavior pain scale (Comfort-B) score measuring pain and comfort of the premature infant before during and after skin-to-skin contact
The "Comfort-Behavior" pain scale will be used 10 minutes after the installation. Immediately after the end of the session, parents will be given a satisfaction scale regarding the positioning experience and comfort, as well as a body chart on which the parent can note the areas where he or she experienced pain during the session. The Comfort-B score values for 6 items are scored between 1 and 5, generating scores between 6 and 30 points. Scores between 6 and 10 indicate oversedation; scores between 11 and 23 indicate a moderately sedated patient; and scores between 24 and 30 indicate little sedation.
Measured: 3-12 days
Premature Infant Pain Profile-Revised (PIPP-R) pain score measuring pain and comfort of the premature infant before during and after skin-to-skin contact
Between day 3 - 7 of life, and day 10 - 12 of life the Premature Infant Pain Profile-Revised (PIPP-R) pain scale will be performed when the child is put in the sling (or headband). PIPP-R is scored for 7 items on a 4-point scale (0, 1, 2, 3) , and are summed for a total pain intensity score between 6 and 28, higher score indicates more pain.
Measured: 3-12 days
Position of joints and muscle tone observed by osteopath or physiotherapist and evaluated by joint, posture and muscle tone assessment -JPMA established by the investigators
-Between day 2-6 of life and at hospital discharge, an osteopath or a physiotherapist, blind to the assignment of groups, will carry out a global observation of the child's posture, joint mobility and muscular tension assessment (JPMA), according to a questionnaire - predefined scale established by the investigators (Appendix IV). This assessment will be performed gently, when the baby is awake in the presence of the nurse in charge of the infant as well as the infant's parents if they so wish. This newly developed assessment scale is based upon existing scales developed for elder infants. Between day 18-22 of life, JPMA will be performed again by a physiotherapist or osteopath. At the same time, an evaluation of the physiological parameters during the skin-to-skin by means of the SCRIP score will be performed. At discharge, the JPMA will be performed too. Score is between 0-4, 4 being the worst
Measured: 2 days-12 weeks
Parental psychological wellbeing - French version of the Parental Stressor Scale (PSS)
Immediately after signing the consent form, and at day 18-22 of admission, the French version of the Parental Stressor Scale (PSS) will be given to each parent to complete individually. Each envelope containing the questionnaires will then be sealed by the parent and given to the examiners. The envelope will only be opened at the end of the child's care and only for the purpose of collecting data for the study. Before discharge, parents will be asked to complete PSS again as well as the visual analog scale regarding satisfaction and interactions with their infant during skin-to-skin contact. Score between 0-40, high score indicate worsening stress.
Measured: 1 day-22 days
Parental psychological wellbeing - the Edinburgh Postnatal Depression Scale (EPDS)
Immediately after signing the consent form, and at day 18-22 of admission, the Edinburgh Postnatal Depression Scale (EPDS) will be given to each parent to complete individually. Each envelope containing the questionnaires will then be sealed by the parent and given to the examiners. The envelope will only be opened at the end of the child's care and only for the purpose of collecting data for the study. Before discharge, parents will be asked to complete EPDS again as well as the visual analog scale regarding satisfaction and interactions with their infant during skin-to-skin contact. Score between 0-30, 7-13 mild, 14-19 moderate 20-30 severe depression.
Measured: 1 day-22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Oct 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Skin-to-skinStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorottya kelen, Erasme University Hospital
- Investigators
- Dorottya Kelen, Principal investigator, Head of Neonatal Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154148
- Sponsor's protocol ID
- P2021/338 B4062021000175
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
PubMed 26447264Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.
PubMed 27552521Puthussery S, Chutiyami M, Tseng PC, Kilby L, Kapadia J. Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews. BMC Pediatr. 2018 Jul 9;18(1):223. doi: 10.1186/s12887-018-1205-9.
PubMed 29986683Coskun D, Gunay U. The Effects of Kangaroo Care Applied by Turkish Mothers who Have Premature Babies and Cannot Breastfeed on Their Stress Levels and Amount of Milk Production. J Pediatr Nurs. 2020 Jan-Feb;50:e26-e32. doi: 10.1016/j.pedn.2019.09.028. Epub 2019 Oct 28.
PubMed 31672261Pados BF, Hess F. Systematic Review of the Effects of Skin-to-Skin Care on Short-Term Physiologic Stress Outcomes in Preterm Infants in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2020 Feb;20(1):48-58. doi: 10.1097/ANC.0000000000000596.
PubMed 30893092Buil A, Carchon I, Apter G, Laborne FX, Granier M, Devouche E. Kangaroo supported diagonal flexion positioning: New insights into skin-to-skin contact for communication between mothers and very preterm infants. Arch Pediatr. 2016 Sep;23(9):913-20. doi: 10.1016/j.arcped.2016.04.023. Epub 2016 Jul 4.
PubMed 27388909Vaivre-Douret L, Ennouri K, Jrad I, Garrec C, Papiernik E. Effect of positioning on the incidence of abnormalities of muscle tone in low-risk, preterm infants. Eur J Paediatr Neurol. 2004;8(1):21-34. doi: 10.1016/j.ejpn.2003.10.001.
PubMed 15023372Ferrari F, Bertoncelli N, Gallo C, Roversi MF, Guerra MP, Ranzi A, Hadders-Algra M. Posture and movement in healthy preterm infants in supine position in and outside the nest. Arch Dis Child Fetal Neonatal Ed. 2007 Sep;92(5):F386-90. doi: 10.1136/adc.2006.101154. Epub 2007 Mar 7.
PubMed 17344252Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.
PubMed 24503979
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion (SDF) With Sling Versus Traditional Prone Position With Headband During Skin-to-skin Care Session
- ClinicalTrials.gov ID
- NCT06154148
- Acronym / sponsor ID
- P2021/338 B4062021000175
- Conditions
- Skin-to-skin, Preterm Birth
- Keywords
- Kangaroo Care, Skin-to-skin, Sustained diagonal flexion, skin-to-skin contact time, Joint mobility and muscular tension assessment, Preterm, Family centered care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Dec 2023 (actual)
- 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.
This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the daily duration of skin-to-skin contact.
Detailed description
This is a prospective, controlled, randomized, non-blinded trial, recruiting premature infants between 27- 34 weeks of gestational age during the first 4 days of life.
80 parent-infant dyads will be recruited in the Department of Neonatology (GA between 27 and 34 weeks) and randomly divided in two groups. Each dyads will be assigned to one of the two skin-to-skin positions.
The study aims to investigate if the sustained diagonal flexion method (SDF) provides additional benefits for both the child and their parents, such as increase in daily skin-to-skin time and its continuation after discharge.
The investigators will analyze the daily duration of skin-to-skin, the cardiorespiratory stability of the child (number of incidents recorded by standard monitoring), the presence of pain during: installation /skin-to-skin/ after the return to the incubator, the continuation of skin-to-skin, breastfeeding after discharge, the risk of postpartum depression in the mother, parental stress, joint mobility and muscle tension of the child and their parents, and also the comfort and satisfaction with the type of skin-to-skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained Diagonal Flexion positioning | Experimental | Procedure: Sustained Diagonal Flexion positioningThis position is a semi reclined positioning, the premature infant is off-center and semi-reclined on the mother's chest its body-axis is slightly flexed, with the limbs retracted in a preventive posture and the head in line with the body axis, moderately externally rotated hips in flexion-abduction, with adducted shoulders. The infants's head turns toward the mother's face and is located between the nipple and the clavicle. Their arms and legs are flexed, in a naturally adopted asymmetrical tonic neck posture, according to the infants's term and comfort. The infant is naked and positioned inside the mother's clothes. |
| Traditional prone position | Active comparator | Procedure: Traditional prone positionThe infants are placed vertically between the mother's breasts firmly attached to the chest and below their clothes. |
Who may qualify
- Ages
- 24 hours to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature infant born between 27 and 34 weeks of gestational age
- Aged between 24 hours and maximum 4 days at the beginning of the study
- Approval from the neonatologist in charge of the patient to participate in the study
- Informed consent of the parents to participate in the study
- At least one of the two parents must have a good knowledge of French.
Key exclusion criteria (5 listed)
- Infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade III or IV)
- Infant or parent who requires or has required surgery during their neonatal stay
- Triplets
- Parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care
- Infant with an arterial line
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 |
|---|---|---|
| Sustained Diagonal Flexion positioningAlso: FDSThis position is a semi reclined positioning, the infant is off-center and semi-reclined on the mother's chest its body-axis is slightly flexed, with the limbs retracted in a preventive posture and the head in line with the body axis, moderately externally rotated hips in flexion-abduction, with adducted shoulders. The infant's head turns toward the mother's face and is located between the nipple and the clavicule. Their arms and legs are flexed,in a naturally adopted asymmetrical tonic neck posture, according to the infant's term and comfort. The infant is naked and positioned inside the mother's clothes. | Procedure or surgery | Sustained Diagonal Flexion positioning |
| Traditional prone positionThe infant is placed vertically between the mother's breasts firmly attached to the chest and below their clothes. | Procedure or surgery | Traditional prone position |
Primary outcome
Daily duration of skin-to-skin during postnatal hospitalisation
Time frame: during hospitalisation
Investigate the effect of skin-to-skin position of premature infants in supported diagonal flexion (SDF) by a sling on daily duration of skin to skin contact during hospitalization (Measured in minutes per day. )
Continuation of skin-to-skin after discharge
Time frame: 6 months
Time spent in a sling by 6 months of age. (Measured in minutes per day)
9 secondary outcomes
Breastfeeding at discharge and at 1, 3, 6 month of age
Time frame: 6 months
Cardiovascular stability of the infant
Time frame: 3-12 weeks
Physiological parameters via Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score
Time frame: 3-22 days
Physiological parameters via Newborn Infant Parasympathetic Evaluation (NIPE) scores
Time frame: 3-22 days
Comfort-Behavior pain scale (Comfort-B) score measuring pain and comfort of the premature infant before during and after skin-to-skin contact
Time frame: 3-12 days
Premature Infant Pain Profile-Revised (PIPP-R) pain score measuring pain and comfort of the premature infant before during and after skin-to-skin contact
Time frame: 3-12 days
Position of joints and muscle tone observed by osteopath or physiotherapist and evaluated by joint, posture and muscle tone assessment -JPMA established by the investigators
Time frame: 2 days-12 weeks
Parental psychological wellbeing - French version of the Parental Stressor Scale (PSS)
Time frame: 1 day-22 days
Parental psychological wellbeing - the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 1 day-22 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Results publication: PubMed 26447264WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
- Results publication: PubMed 27552521Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.
- Results publication: PubMed 29986683Puthussery S, Chutiyami M, Tseng PC, Kilby L, Kapadia J. Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews. BMC Pediatr. 2018 Jul 9;18(1):223. doi: 10.1186/s12887-018-1205-9.
- Results publication: PubMed 31672261Coskun D, Gunay U. The Effects of Kangaroo Care Applied by Turkish Mothers who Have Premature Babies and Cannot Breastfeed on Their Stress Levels and Amount of Milk Production. J Pediatr Nurs. 2020 Jan-Feb;50:e26-e32. doi: 10.1016/j.pedn.2019.09.028. Epub 2019 Oct 28.
- Results publication: PubMed 30893092Pados BF, Hess F. Systematic Review of the Effects of Skin-to-Skin Care on Short-Term Physiologic Stress Outcomes in Preterm Infants in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2020 Feb;20(1):48-58. doi: 10.1097/ANC.0000000000000596.
- Results publication: PubMed 27388909Buil A, Carchon I, Apter G, Laborne FX, Granier M, Devouche E. Kangaroo supported diagonal flexion positioning: New insights into skin-to-skin contact for communication between mothers and very preterm infants. Arch Pediatr. 2016 Sep;23(9):913-20. doi: 10.1016/j.arcped.2016.04.023. Epub 2016 Jul 4.
- Results publication: PubMed 15023372Vaivre-Douret L, Ennouri K, Jrad I, Garrec C, Papiernik E. Effect of positioning on the incidence of abnormalities of muscle tone in low-risk, preterm infants. Eur J Paediatr Neurol. 2004;8(1):21-34. doi: 10.1016/j.ejpn.2003.10.001.
- Results publication: PubMed 17344252Ferrari F, Bertoncelli N, Gallo C, Roversi MF, Guerra MP, Ranzi A, Hadders-Algra M. Posture and movement in healthy preterm infants in supine position in and outside the nest. Arch Dis Child Fetal Neonatal Ed. 2007 Sep;92(5):F386-90. doi: 10.1136/adc.2006.101154. Epub 2007 Mar 7.
- Results publication: PubMed 24503979Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.
- Individual participant dataSharing planned: No
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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.
Dorottya Kelen principal investigator
Head of Neonatal Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Diagonal Flexion positioning and Traditional prone position in people with Skin-to-skin and Preterm Birth, run by Erasme University Hospital at 1 site in Belgium.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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 Belgium. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorottya Kelen, MD (025553430 ext. 3430, dorottya.kelen@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily duration of skin-to-skin during postnatal hospitalisation (time frame: during hospitalisation). The study lists 2 primary outcomes in all. 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 NCT06154148, which also lists 9 linked publications.
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 15 Dec 2023.