Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

Not Applicable

Completed

• Conditions: Premature Infants
• Interventions: Behavioral: Complete oral feeding intervention; Behavioral: Routine nursing care group

• Registration Number: NCT05208437
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

Detailed Description

In order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

Study Timeline

• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Study Start: 2022-02-01
• Status Verified: 2023-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Gestational age <32w;
• Admit within 72 hours of birth;
• The guardian signs the informed consent;
• OI (oxygenation index >300)

Exclusion Criteria

• Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
• Newborns who die during the study;
• Newborns who drop out of the study;
• Newborns who have NEC during hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete oral feeding intervention group	Complete oral feeding intervention	Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale. Feeding of premature infants using different interventions based on the results of the Feeding Preparation Scale.
Routine nursing care group	Routine nursing care group	Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. Routine nursing care is identical to the control group.

Primary Outcome Measures

Name	Time	Method
Transition time from the initiation oral feeding to full oral feeding	During the procedure	Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.; time of complete oral feeding

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China