Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants

Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention

This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.

All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.

Study Overview

• Status: Completed
• Conditions: Risky Baby
• Intervention / Treatment: Other: Family Care Intervention

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Afyonkarahisar, Turkey (Türkiye)
    • Afyonkarahisar Health Sciences University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• Infants diagnosed as neurodevelopmentally at risk.
• Infants born between 37 and 40 gestational weeks.
• Infants with a birth weight below 2500 grams.
• Infants who have been admitted to the neonatal intensive care unit for at least 10 days since birth.

Exclusion Criteria:

• Infants whose families declined participation in the study.
• Infants with congenital anomalies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Family Care Intervention

Other: Family Care Intervention; A structured, family care education was provided to parents of hospitalized neonates. The session focused on promoting parental involvement in infant care, reducing parental anxiety and depression, and minimizing neonatal pain. The intervention was delivered individually to each parent-infant dyad during hospitalization and included guidance on routine neonatal care, recognizing and responding to infant cues, and supportive strategies for high-risk infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Care Participation	In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.	1 year
Edinburgh Postnatal Depression Scale	In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.	1 year
State-Trait Anxiety	In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.	1 year
Neonatal Pain	In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological Risk Level	In this study, neurological risk level was assessed using the Dubowitz Neurological Examination. This standardized assessment evaluates neonatal neurological function, including tone, reflexes, movements, and behavioral responses. The total score ranges from 0 to 34, with higher scores indicating better neurological status and lower neurological risk.	1 year

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: E-69996495-100-34196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No