The prevention of developmental and behavioral problems of very preterm infants and parental stress through the use of development care: An intervention program for infants and parents.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28923

Enrollment

360

Registered

2005-09-07

Start date

2000-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, neonatal intensive care, NIDCAP, developmental care, outcome at 1 and 2 years.

Interventions

Two interventions (randomized control trials) in two consecutive phases: Phase 1: Reducing environmental stress through the use of covers over the incubators to decrease excess light and sound, the

Eligibility

Inclusion criteria

Inclusion criteria: All premature infants with a gestational age of 32 weeks or less admitted to the neonatal intensive care unit of LUMC and JKZ hospitals in the health region of Leiden, Delft, The Hague and Gouda for a period of at least 5 days.

Exclusion criteria

Exclusion criteria: Infants of drug-addicted mothers and infants with cardiac problems or other major birth anomalies, or those requiring surgery.

Design outcomes

Secondary

Measure	Time frame
After inclusion of both interventions in the 2 phases a self-made questionnaire was given to the nursing and medical staff to assess the implementation of the NIDCAP intervention.	—

Primary

Measure	Time frame
During hospital admission: Number of days requiring mechanical ventilation, CPAP or oxygen therapy; number of days with reported apnea episodes; growth (weekly weight gain and increase of head circumference) morbidity Parental Stress Scale-NICU (PSS-NICU), The Nurse Parent Support Tool (NPST) and Mothers and Babies Scale (MABS). At follow-up; The infants participating in the study are examined at term age and after 1 and 2 years in the follow-up clinics of the LUMC and JKZ. At term age: A full medical history (including behavior) and physical examination, growth parameters, Prechtl neurological assessment and cerebral ultrasound. At 1 year of age (corrected for prematurity): Medical examination and growth parameters (weight, length and head circumference). Touwen neurological assessment. Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSID II). Behavioral outcomes will be assessed through a parental questionnaire (ITSEA). Parental stress through the Nijmeegse parental stress index (NOSI(K)) questionnaire and Health Related Quality of life through the (TAPCQOL) questionnaire. - At 2 years of age (corrected for prematurity): Medical examination and growth parameters (weight, length and head circumference). Hempel neurological assessment. - Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSIDII). - Behavioral outcomes will be assessed through the CBCL(Child Behavior list), parental stress through the NOSI(K)-Nijmeegse parental stress index and Health Related Quality of life through the (TAPCQOL) questionnaires. In phase 2; 2 additional questionnaires: - 3 months: condition of infant (baby-KIPPPI) - 9 months: infant behavior (IBQ).	—

Measure

Time frame

During hospital admission: Number of days requiring mechanical ventilation, CPAP or oxygen therapy; number of days with reported apnea episodes; growth (weekly weight gain and increase of head circumference) morbidity Parental Stress Scale-NICU (PSS-NICU), The Nurse Parent Support Tool (NPST) and Mothers and Babies Scale (MABS). At follow-up; The infants participating in the study are examined at term age and after 1 and 2 years in the follow-up clinics of the LUMC and JKZ. At term age: A full medical history (including behavior) and physical examination, growth parameters, Prechtl neurological assessment and cerebral ultrasound. At 1 year of age (corrected for prematurity): Medical examination and growth parameters (weight, length and head circumference). Touwen neurological assessment. Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSID II). Behavioral outcomes will be assessed through a parental questionnaire (ITSEA). Parental stress through the Nijmeegse parental stress index (NOSI(K)) questionnaire and Health Related Quality of life through the (TAPCQOL) questionnaire. - At 2 years of age (corrected for prematurity): Medical examination and growth parameters (weight, length and head circumference). Hempel neurological assessment. - Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2-30 Bayley developmental scales / BSIDII). - Behavioral outcomes will be assessed through the CBCL(Child Behavior list), parental stress through the NOSI(K)-Nijmeegse parental stress index and Health Related Quality of life through the (TAPCQOL) questionnaires. In phase 2; 2 additional questionnaires: - 3 months: condition of infant (baby-KIPPPI) - 9 months: infant behavior (IBQ).

—

Contacts

Public ContactCeleste Maguire

Leiden University Medical Center (LUMC), Department of Pediatrics, J6-S, P.O. Box 9600

c.m.maguire@lumc.nl+31 (0)71 5264082

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)