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

Free University of Brussels (ULB)

Status: Enrolling

Conditions: Skin-to-skin; Preterm Birth

Treatments: Procedure: Sustained Diagonal Flexion positioning; Procedure: Traditional prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT06154148

P2021/338 B4062021000175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 24 hours to 4 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Sustained Diagonal Flexion positioning

Experimental group

Description:

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.

Treatment:

Procedure: Sustained Diagonal Flexion positioning

Traditional prone position

Active Comparator group

Description:

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

Treatment:

Procedure: Traditional prone position