Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154148
• Other study ID #: P2021/338 B4062021000175
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2023
• Source: Erasme University Hospital
• Contact: Dorottya Kelen, MD
• Phone: 025553430
• Email: dorottya.kelen[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 daily duration of skin-to-skin contact.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Skin-to-skin

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Neonatal Unit Hopital Erasme	Brussels	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (9)

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 — View 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. — View 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 — View 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 — View 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. — View 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. — View 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. — View 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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. )	during hospitalisation
Primary	Continuation of skin-to-skin after discharge	Time spent in a sling by 6 months of age. (Measured in minutes per day)	6 months
Secondary	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.	6 months
Secondary	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)	3-12 weeks
Secondary	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.	3-22 days
Secondary	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.	3-22 days
Secondary	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.	3-12 days
Secondary	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.	3-12 days
Secondary	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	2 days-12 weeks
Secondary	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.	1 day-22 days
Secondary	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.	1 day-22 days