The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge

Parents Clinical Trial

Official title:

Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478162
• Other study ID #: 16214662/050.01.04/14
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: December 2023
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home. Different approaches and models are applied in the Neonatal Intensive Care Units (NICU) to prepare families, especially mothers, for the discharge process and to overcome these fears of the parents. However, most of the time, investigators observe in both researches and units that these approaches are not efficient. In this study, which investigators started with the questions as "What can investigators do better in this issue?" and "How can investigators help families more in this process?", investigator have seen that Family Integrated Care (FICare) model is applied in some clinics abroad and successful results have been obtained. However, investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge. Since this study will be a first in terms of both this aspect and the application of this model in our country, in this unique study, investigators aim to draw attention to this approach in our country, also contribute to keeping the premature babies healthy.

Research Hypotheses:

H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group.

H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group.

H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group.

Description:

Background: The Family Integrated Care (FICare) model is a modern approach that supports the participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug administration) developed in collaboration between parents and healthcare professionals, which is carried out gradually in the NICU (1). Parents are informed about the general development of the baby, brain and sensory development, motor and behavior development, care of the premature. In addition, parents are informed about what they can do about general body cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in parental stress, a significant decrease in critical incident reports such as hospital infection and sudden infant death (3). The care that these babies receive in their first hours, days, weeks and months is vital to determine their future health and long-term outcomes. Evidence suggests that if parents are supported and encouraged to take care of their babies while in hospital, this will have better outcomes for both the baby and their family. FICare support not only reduces the length of hospital stay of parents, but also reduces the rate of re-hospitalization, and strengthens the bond between parents and babies. It helps parents feel safer when taking care of their babies, both in the hospital and at home (4).

A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU. Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit. With the FICare model, it is thought that parents will be prepared for discharge, bonding between parents and babies, fulfilling their parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing parental-employee communication, and increasing the quality of care services..

Premature infants who were hospitalized for at least seven days between February 6, 2020, and August 15, 2021, in the NICU of a training and research hospital formed the population of the study. In the study, the total number of parents was determined as 68 when the margin of error was 5%, the power level was 81.17%, and the effect size value was 0.70. At the end of the study, a post hoc power analysis was conducted to determine the adequacy of the sample size. As a result of the power analysis, for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 1.990, and the power level according to the structure was determined as 1.000. To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 2.586 and power level according to temperature was determined as 1.000. These values show that the sample size is sufficient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Birth of the infant at the 28th-34th weeks of gestation,

2. First parenting experience of the mother and the father,

3. Parents' willingness to participate in the study and being open to communication,

4. Mother having breast milk,

5. Participation of parents in the discharge training program.

Exclusion Criteria:

1. Undergoing a surgical intervention,

2. Death of the baby

3. Transfer of the baby to another hospital,

4. Failure of the parent to complete all phases of the study.

Related Conditions & MeSH terms

• Neonatal Intensive Care Unit
• Parents

Intervention

Other:
• Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.
At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,

Locations

Country	Name	City	State
Turkey	Sakarya Education and Training Hospital	Sakarya	Adapazari

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.	With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.	up to nine months
Secondary	Premature infants weight (kg)	Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.; Measurements obtained by the percentile curve are evaluated.	up to nine months

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