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

NCT06154148 | Unknown

• 1 other identifier: P2021/338 B4062021000175
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Breastfeeding at discharge and at 1, 3, 6 month of age

  6 months

• Cardiovascular stability of the infant

  3-12 weeks

• Physiological parameters via Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score

  3-22 days

• Physiological parameters via Newborn Infant Parasympathetic Evaluation (NIPE) scores

  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

  3-12 days

Study Arms (2)

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.

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.

Procedure: Traditional prone position

Interventions

Sustained Diagonal Flexion positioning PROCEDURE

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.

Also known as: FDS

Sustained Diagonal Flexion positioning

Traditional prone position PROCEDURE

The infant is placed vertically between the mother's breasts firmly attached to the chest and below their clothes.

Traditional prone position

Eligibility Criteria

• Age: 24 Hours - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Neonatal Unit Hopital Erasme

Brussels, Anderlecht, 1070, Belgium

RECRUITING

Related Publications (9)

• WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/

  PMID: 26447264 RESULT

• 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.

  PMID: 27552521 RESULT

• 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.

  PMID: 29986683 RESULT

• 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.

  PMID: 31672261 RESULT

• 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.

  PMID: 30893092 RESULT

• 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.

  PMID: 27388909 RESULT

• 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.

  PMID: 15023372 RESULT

• 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.

  PMID: 17344252 RESULT

• 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.

  PMID: 24503979 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dorottya Kelen

  Head of Neonatal Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorottya Kelen, MD

CONTACT

025553430; dorottya.kelen@erasme.ulb.ac.be

Laura Maroye

CONTACT

025558103; Laura.Maroye@erasme.ulb.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neonatal Unit

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: December 1, 2023
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)