- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02998463
Facilitating Skin-to-Skin Contact In the Postnatal Period
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
West Midlands
-
Birmingham, West Midlands, 영국, B15 3TN
- Birmingham City University
-
Birmingham, West Midlands, 영국, B15 3TN
- Sandwell and West Birmingham NHS Trust
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Snuby® users
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.
|
Fabric garment designed to accommodate term neonates having skin-to-skin contact.
다른 이름들:
|
|
간섭 없음: Conventional Care
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Abnormal neonatal temperature
기간: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
|
Axillary temperature taken by the mother with Eco Temp Basic thermometer.
Abnormal: less than 36.5°C or more than 37.5°C.
|
Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Breastfeeding Status
기간: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
|
Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk.
Includes a comparison to self reported antenatal infant feeding intentions.
|
Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
|
|
Mother Infant bonding
기간: Six weeks post birth
|
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.
|
Six weeks post birth
|
|
Neonatal Weight Velocity
기간: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
|
Neonatal weight in grams to ensure suitable for Snuby® garment.
|
At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
|
|
Maternal participant's perspective
기간: Weekly until 6 weeks post birth
|
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.
|
Weekly until 6 weeks post birth
|
|
Midwifery participant's perspective
기간: 12 months post birth of the first participating mother-infant dyad.
|
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.
|
12 months post birth of the first participating mother-infant dyad.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Helen McIntyre, DHSci, University of Leicester
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .