Clinical trial NCT06154148: Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Daily duration of skin-to-skin during postnatal hospitalisation
timeFrame: during hospitalisation
measure: Continuation of skin-to-skin after discharge
timeFrame: 6 months
Secondary outcomes:
measure: Breastfeeding at discharge and at 1, 3, 6 month of age
timeFrame: 6 months
measure: Cardiovascular stability of the infant
timeFrame: 3-12 weeks
measure: Physiological parameters via Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score
timeFrame: 3-22 days
measure: Physiological parameters via Newborn Infant Parasympathetic Evaluation (NIPE) scores
timeFrame: 3-22 days
measure: Comfort-Behavior pain scale (Comfort-B) score measuring pain and comfort of the premature infant before during and after skin-to-skin contact
timeFrame: 3-12 days
measure: 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
timeFrame: 3-12 days
measure: 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
timeFrame: 2 days-12 weeks
measure: Parental psychological wellbeing - French version of the Parental Stressor Scale (PSS)
timeFrame: 1 day-22 days
measure: Parental psychological wellbeing - the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 1 day-22 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Neonatal Unit Hopital Erasme
state: Anderlecht
Study officials:
affiliation: Head of Neonatal Unit
name: Dorottya Kelen
role: PRINCIPAL_INVESTIGATOR
References:
citation: WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.