A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.

NCT04987983 | Completed

• 1 other identifier: PMMHRI-2021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology. One of the areas that can help improve feeding is choosing the optimal feeding position for premature babies.

Conditions

Bottle Feeding; Premature

Keywords

Premature Infant; Bottle Feeding; Side-lying Position; Oral Feeding

Outcome Measures

Primary Outcomes (10)

• Physiological stability

  Oxygen saturation (SpO2) changes measured by using a pulse oximeter data

  Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)

• Physiological stability

  Heart rate (HR) changes measured by using a pulse oximeter data

  Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)

• Qualitative aspect of bottle-feeding

  Total time of declines of SpO2 ≤85% measured by using a pulse oximeter data

  Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

• Qualitative aspect of bottle-feeding

  Level of the newborn's alertness changes according to the 6-point Neonatal Behavioral Assessment Scale, where individual points mean: 1 - quiet sleep, 2 - active sleep, 3 - drowsy, 4 - quiet alert, 5 - active alert, 6 - crying. This is descriptive, qualitative scale which shows changes of newborn's activity.

  Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)

• Qualitative aspect of bottle-feeding

  Occurrence of choking episodes

  Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

• Qualitative aspect of bottle-feeding

  Occurence of posseting and regurgitations

  Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

• Qualitative aspect of bottle-feeding

  Duration of the feeding session

  Up to 1 hour - measured from taking the baby out of bed before feeding to putting the baby to bed immediately after the intervention. Putting baby on parent's chest to kangaroo (Kangaroo Mother Care) after feeding instead to bed was also allowed.

• Qualitative aspect of bottle-feeding

  Duration of feeding

  Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes) - measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding

• Qualitative aspect of bottle-feeding

  Duration of feeding

  Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes) - duration of feeding is measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding

• Qualitative aspect of bottle-feeding

  Proportion of milk consumed (volume of milk eaten relative to the expected volume)

  Measured in 10th minute of feeding and on the finish of the feeding - maximum in 40th minute of feeding (maximum time of feeding is 40 minutes)

Study Arms (2)

Experimental SLP-R

EXPERIMENTAL

Infant placed in a SLP-R on the researcher's lap. Infant body positioned on side-lying position on the right side of it's body. Head of the infant symmetrically placed between the shoulders, supported by the researcher's. Shoulder girdle higher than the pelvic girdle, head and back in a straight line - a slight natural bend of the body is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands)

Other: Experimental SLP-R

Experimental SLP-L

EXPERIMENTAL

Infant placed in a SLP-L on the researcher's lap. Infant body positioned on side-lying position on the left side of it's body. Head of the infant symmetrically placed between the shoulders, supported by the researcher's. Shoulder girdle higher than the pelvic girdle, head and back in a straight line - a slight natural bend of the body is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands).

Other: Experimental SLP-L

Interventions

Experimental SLP-R OTHER

SLP-R will be given to the infant during bottle-feeding.

Experimental SLP-R

Experimental SLP-L OTHER

SLP-L will be given to the infant during bottle-feeding.

Experimental SLP-L

Eligibility Criteria

• Age: 32 Weeks - 38 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• circulatory and respiratory stability;
• readiness for oral feeding according to each child's Speech-Language Pathologist assessment;
• prematurely born infants who will be in the process of transfer from enteral nutrition to full oral feeding and will be fed orally at least 4 times within twenty-four hours;
• researcher must be a right handed person (right hand is the dominant hand);
• each infant will be fed with one kind of bottle and nipple;
• parents will give a informed consent to participate their infant in the study.

You may not qualify if:

• disorders which could significantly affect the feeding course, such as cleft lip and/or palate, facial paralysis and/or congenital defects of the facial skeleton;
• the presence of detected congenital abnormalities and metabolic diseases;
• newborns after abdomen chirurgical treatment;
• low Apgar score (less than 5 points at the 5th and 10th minute of the measurement);
• administered analgesics, anticonvulsants and sedatives \<72 hours from extubation prior the trial;
• parenterally fed infants;
• infants with administered intravenous infusion with glucose;
• parents refusal to participate in the study or when bottle-feeding will not be the parental preference.

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Polish Mother's Memorial Hospital - Research Institute

Lodz, 93-338, Poland

Location

MeSH Terms

Conditions

Bottle Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anna D Raczyńska, PhD

  Polish Mother's Memorial Hospital - Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 3, 2021
• Study Start: June 28, 2021
• Primary Completion: September 8, 2021
• Study Completion: September 23, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)