search
Back to results

The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants

Primary Purpose

Preterm Infant

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Skin-to-skin contact
Routine care
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant focused on measuring Stress response, Skin-to-skin contact, Cortisol

Eligibility Criteria

0 Hours - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 31 weeks≤gestational age<37 weeks;
  • Birth weight ≥ 1500g;
  • Admission age < 24h;
  • No congenital malformations;
  • Vital signs are stable and does not use ventilator and other auxiliary life support systems.

Exclusion Criteria:

  • Severe periventricular / intraventricular hemorrhage (grade III);
  • Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
  • Mother unable to communicate and communicate normally; Mother has a history of depression.

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Skin-to-skin contact group

Routine care group

Arm Description

Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.

Perform routine nursing care for preterm infants in the neonatal intensive care unit.

Outcomes

Primary Outcome Measures

Changes on the concentration of cortisol of preterm infants
At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.

Secondary Outcome Measures

Changes on the level of cortisol during heel lancet
At 7 days of life, saliva sample will collected from preterm infants by a neonatal nurse before and 30 mins after heel lancet.
Score of Edinburgh Postnatal Depression Scale
Mothers' depression status will be measure by Edinburgh Postnatal Depression Scale through WeChat at discharge day. The questionnaire is a self screening tool, contains 10 items, each item is scored from 0-3 according to a 4-point Likert scale , and the total score is 0-30 points. The higher the score, the more severe the depression. All the questionnaires will collect and calculate by a neonatal nurse.
Length of hospital stays
Duration of hospitalization will calculate from the date of admission to the date of discharge, which obtained from clinical records files.
Crying time
At 7 days of life, crying time will be recorded and calculated by a neonatal nurse during heel lancet.

Full Information

First Posted
July 31, 2022
Last Updated
August 9, 2023
Sponsor
Children's Hospital of Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05503238
Brief Title
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
Official Title
The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
Detailed Description
Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
Keywords
Stress response, Skin-to-skin contact, Cortisol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin-to-skin contact group
Arm Type
Experimental
Arm Description
Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.
Arm Title
Routine care group
Arm Type
Other
Arm Description
Perform routine nursing care for preterm infants in the neonatal intensive care unit.
Intervention Type
Behavioral
Intervention Name(s)
Skin-to-skin contact
Intervention Description
Preterm infants will receive maternal-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge, and other nursing care will be same as the routine group. During skin-to-skin contact, place naked baby only with diaper on the mother's bare chest in an upright position and tilt the baby's head to one side in a slightly extended position to keeps the airway open, cover the infant with a blanket to keep them warm. A neonatal nurse will be stay with mother and infant to observe and support.
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.
Primary Outcome Measure Information:
Title
Changes on the concentration of cortisol of preterm infants
Description
At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.
Time Frame
From 3 days of life (baseline) to 7 days of life
Secondary Outcome Measure Information:
Title
Changes on the level of cortisol during heel lancet
Description
At 7 days of life, saliva sample will collected from preterm infants by a neonatal nurse before and 30 mins after heel lancet.
Time Frame
At the preterm infants 7 days of life
Title
Score of Edinburgh Postnatal Depression Scale
Description
Mothers' depression status will be measure by Edinburgh Postnatal Depression Scale through WeChat at discharge day. The questionnaire is a self screening tool, contains 10 items, each item is scored from 0-3 according to a 4-point Likert scale , and the total score is 0-30 points. The higher the score, the more severe the depression. All the questionnaires will collect and calculate by a neonatal nurse.
Time Frame
Through study completion, an average of 40 days
Title
Length of hospital stays
Description
Duration of hospitalization will calculate from the date of admission to the date of discharge, which obtained from clinical records files.
Time Frame
Through study completion, an average of 40 days
Title
Crying time
Description
At 7 days of life, crying time will be recorded and calculated by a neonatal nurse during heel lancet.
Time Frame
At the preterm infants 7 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 31 weeks≤gestational age<37 weeks; Birth weight ≥ 1500g; Admission age < 24h; No congenital malformations; Vital signs are stable and does not use ventilator and other auxiliary life support systems. Exclusion Criteria: Severe periventricular / intraventricular hemorrhage (grade III); Receiving sedation or vasopressor or analgesics opiodis and corticosteroids; Mother unable to communicate and communicate normally; Mother has a history of depression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjuan Han, Master
Phone
+8613020123256
Email
hanxi1128@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojing Hu, PHD
Phone
+8618017590869
Email
humama2015@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing Hu
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants

We'll reach out to this number within 24 hrs