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Facilitating Skin-to-Skin Contact In the Postnatal Period

Primary Purpose

Breast Feeding, Body Temperature Changes

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

skin-to-skin facilitating garment

About this trial

This is an interventional other trial for Breast Feeding focused on measuring Skin-to-skin, Kangaroo Care, Kangaroo Mother Care

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Maternal participants

Inclusion Criteria:

Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby.

Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home.

Exclusion Criteria:

Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old.

Neonatal participants

Inclusion criteria:

Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age.

Exclusion criteria:

Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old.

Midwifery staff participants

Inclusion Criteria:

Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting.

Exclusion Criteria:

Midwifery staff working in the community without rotating to the hospital wards.

Sites / Locations

Birmingham City University
Sandwell and West Birmingham NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Snuby® users

Conventional Care

Arm Description

This group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period.

This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant.

Outcomes

Primary Outcome Measures

Abnormal neonatal temperature

Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.

Secondary Outcome Measures

Breastfeeding Status

Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.

Mother Infant bonding

Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.

Neonatal Weight Velocity

Neonatal weight in grams to ensure suitable for Snuby® garment.

Maternal participant's perspective

Maternal participants will self-report their views on the garment's ease of use and perceived value. This will be compared to the control group reporting on the same outcomes with conventionally facilitated skin-to-skin contact.

Midwifery participant's perspective

Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.

Full Information

NCT ID

NCT02998463

First Posted

December 14, 2016

Last Updated

July 25, 2019

Sponsor

Birmingham City University

1. Study Identification

Unique Protocol Identification Number

NCT02998463

Brief Title

Facilitating Skin-to-Skin Contact In the Postnatal Period

Official Title

A Skin-to-Skin Contact (SSC) Facilitating Device Used Within a Mother-Infant Dyad: Exploring Its Acceptability, Usage and Effect on Health Outcomes in the Postnatal Period.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 31, 2017 (Actual)

Primary Completion Date

June 20, 2019 (Actual)

Study Completion Date

June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Birmingham City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.

Detailed Description

Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world. This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (Charpak and Ruiz 2016). This study examines the effect a facilitating garment, the Snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Feeding, Body Temperature Changes

Keywords

Skin-to-skin, Kangaroo Care, Kangaroo Mother Care

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Snuby® users

Arm Type

Experimental

Arm Description

Arm Title

Conventional Care

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

skin-to-skin facilitating garment

Other Intervention Name(s)

Snuby®

Intervention Description

Fabric garment designed to accommodate term neonates having skin-to-skin contact.

Primary Outcome Measure Information:

Title

Abnormal neonatal temperature

Description

Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.

Time Frame

Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.

Secondary Outcome Measure Information:

Title

Breastfeeding Status

Description

Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.

Time Frame

Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.

Title

Mother Infant bonding

Description

Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.

Time Frame

Six weeks post birth

Title

Neonatal Weight Velocity

Description

Neonatal weight in grams to ensure suitable for Snuby® garment.

Time Frame

At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.

Title

Maternal participant's perspective

Description

Time Frame

Weekly until 6 weeks post birth

Title

Midwifery participant's perspective

Description

Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.

Time Frame

12 months post birth of the first participating mother-infant dyad.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Maternal participants Inclusion Criteria: Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby. Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home. Exclusion Criteria: Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old. Neonatal participants Inclusion criteria: Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age. Exclusion criteria: Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old. Midwifery staff participants Inclusion Criteria: Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting. Exclusion Criteria: Midwifery staff working in the community without rotating to the hospital wards.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen McIntyre, DHSci

Organizational Affiliation

University of Leicester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Birmingham City University

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 3TN

Country

United Kingdom

Facility Name

Sandwell and West Birmingham NHS Trust

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 3TN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27765653

Citation

Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.

Results Reference

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Facilitating Skin-to-Skin Contact In the Postnatal Period

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