Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional
NCT ID: NCT06154148
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2021-10-01
2025-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sustained Diagonal Flexion positioning
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.
Sustained Diagonal Flexion positioning
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 position
The infants are placed vertically between the mother's breasts firmly attached to the chest and below their clothes.
Traditional prone position
The infant is placed vertically between the mother's breasts firmly attached to the chest and below their clothes.
Interventions
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Sustained Diagonal Flexion positioning
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 position
The infant is placed vertically between the mother's breasts firmly attached to the chest and below their clothes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
24 Hours
4 Days
ALL
Yes
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Dorottya kelen
Head of Neonatal Unit
Principal Investigators
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Dorottya Kelen
Role: PRINCIPAL_INVESTIGATOR
Head of Neonatal Unit
Locations
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Neonatal Unit Hopital Erasme
Brussels, Anderlecht, Belgium
Countries
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Central Contacts
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Facility Contacts
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Dorottya Kelen, MD
Role: primary
Laura Maroye
Role: backup
References
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WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
Conde-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.
Puthussery 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.
Coskun 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.
Pados 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.
Buil 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.
Vaivre-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.
Ferrari 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.
Stevens 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.
Other Identifiers
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P2021/338 B4062021000175
Identifier Type: -
Identifier Source: org_study_id